FCC ID: RIAICDRFNGQ Implantable Cardioverter Defibrillator Device

Avant, Neutrino NxT, Gallant, Entrant Cardiac Resynchronization Therapy Defibrillator, Implantable Cardioverter Defibrillator CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. Indicates a trademark of the Abbott group of companies. Indicates a third-party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. Pat. http://www.abbott.com/patents 2023 Abbott. All Rights Reserved. Device Description This manual describes the following Abbott Medical pulse generators:

Table 1. Single-chamber pulse generator descriptions Name Model Number Description Avant VR CDVRA700Q Avant VR CDVRA700T Neutrino NxT VR Neutrino NxT VR CDVRA800Q CDVRA600Q CDVRA800T CDVRA600T Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry Connector Type Delivered Energy

(approx.) MRI Status DF4LLHH 40 J MR Conditional DF1/IS-1 40 J MR Conditional DF4LLHH 40 J MR Conditional DF1/IS-1 40 J MR Conditional 1 Connector Type Delivered Energy

(approx.) MRI Status DF4LLHH 40 J MR Conditional DF1/IS-1 40 J MR Conditional DF4LLHH 36 J MR Conditional DF1/IS-1 36 J MR Conditional Table 1. Single-chamber pulse generator descriptions Name Model Number Description Gallant VR CDVRA500Q Gallant VR CDVRA500T Entrant VR CDVRA300Q Entrant VR CDVRA300T Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry Singlechamber ICD with BLE telemetry DF4 connector cavities comply with ISO 27186. IS-1 connector cavities comply with ISO 5841-3. DF-1 connector cavities comply with ISO 11318. 2 Table 2. Dual-chamber pulse generator descriptions Name Model Number Description Avant DR CDDRA700Q Avant DR CDDRA700T Neutrino NxT DR Neutrino NxT VR CDDRA800Q CDDRA600Q CDDRA800T CDDRA600T Gallant DR CDDRA500Q Gallant DR CDDRA500T Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry 3 Connector Type Delivered Energy

(approx.) MRI Status DF4LLHH/IS1 40 J MR Conditional DF-1/IS-1 40 J MR Conditional DF4LLHH/IS1 40 J MR Conditional DF-1/IS-1 40 J MR Conditional DF4LLHH/IS1 40 J MR Conditional DF-1/IS-1 40 J MR Conditional Table 2. Dual-chamber pulse generator descriptions Name Model Number Description Entrant DR CDDRA300Q Entrant DR CDDRA300T Dualchamber ICD with BLE telemetry Dualchamber ICD with BLE telemetry DF4 connector cavities comply with ISO 27186. IS-1 connector cavities comply with ISO 5841-3. DF-1 connector cavities comply with ISO 11318. Table 3. CRT-D pulse generator descriptions Connector Type Delivered Energy

(approx.) MRI Status DF4LLHH/IS1 36 J MR Conditional DF-1/IS-1 36 J MR Conditional Name Model Number Description Connector Type Delivered MRI Status Avant HF CDHFA700Q CRTD with BLE telemetry DF4LLHH/

IS4LLLL/

IS1 4 Energy

(approx.) 40 J MR Conditional Table 3. CRT-D pulse generator descriptions Name Model Number Description Connector Type Delivered MRI Status Avant HF CDHFA700T Neutrino NxT HF Neutrino NxT HF CDHFA800Q CDHFA600Q CDHFA800T CDHFA600T Gallant HF CDHFA500Q Gallant HF CDHFA500T CRTD with BLE telemetry CRTD with BLE telemetry CRTD with BLE telemetry CRTD with BLE telemetry CRTD with BLE telemetry DF-1/

IS4-LLLL/

IS-1 DF4LLHH/

IS4LLLL/

IS1 DF1LLHH/

IS4LLLL/

IS1 DF4LLHH/

IS4LLLL/

IS1 DF1LLHH/

IS4LLLL/

IS1 5 Energy

(approx.) 40 J 40 J 40 J 40 J 40 J MR Conditional MR Conditional MR Conditional MR Conditional MR Conditional Table 3. CRT-D pulse generator descriptions Name Model Number Description Connector Type Delivered MRI Status Entrant HF CDHFA300Q Entrant HF CDHFA300T CRTD with BLE telemetry CRTD with BLE telemetry DF4LLHH/

IS4LLLL/

IS1 DF1LLHH/

IS4LLLL/

IS1 DF4 and IS4 connector cavities comply with ISO 27186. IS-1 connector cavities comply with ISO 5841-3. DF-1 connector cavities comply with ISO 11318. Energy

(approx.) 36 J MR Conditional 36 J MR Conditional These devices can be programmed with Merlin Patient Care System equipped with Model 3330 version 27.1.1 (or greater) software. For information on programming, refer to the programmer's onscreen help. Models with the Q suffix are functionally equivalent in all respects to the same model with the T suffix, except for the header. Models with the "T suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q suffix use DF4-LLHH lead connectors for the high-voltage leads. 6 Table 4. Accessories and their intended uses Accessory Torque wrench Silicone oil Medical adhesive Magnet Intended use Secure lead connectors and port plugs within the device header. Lubricant Sealant Place over the device to inhibit tachyarrhythmia therapy IS1 Receptacle Plug Seal unused lead receptacles IS4/DF4 Port Plug Seal unused lead receptacles DF-1 Receptacle Plug Seal unused lead receptacles Intended Use The Implantable Cardioverter Defibrillator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat:

chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or right atrium. 7 CRT-D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles. Indications The ICD devices are indicated in patients who have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). Cardiac Resynchronization Therapy (CRT) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (LVEF) and a prolonged QRS duration. CRT-

D devices are indicated in patients who meet the CRT indications and have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). The device is most commonly implanted within a device pocket in the pectoral region. Note: For patient-specific recommendations, such as primary and secondary prevention, refer to the respective current clinical guidelines of the Heart Rhythm Society (HRS), the American Heart Association

(AHA), American College of Cardiology (ACC) or European Society for Cardiology (ESC), as well as those of other national cardiology associations. Intended Clinical Benefits The intended clinical benefits of the Avant, Neutrino NxT, Gallant and Entrant Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) may include the following:

Effective management of ventricular tachycardia (VT) and ventricular fibrillation (VF) Reduction in morbidity and mortality, including risk of sudden cardiac death The intended clinical benefits of the Avant, Neutrino NxT, Gallant and Entrant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) may also include the following:

8 Improvement in cardiac function and performance, heart failure symptoms, exercise tolerance, health-

related quality of life and well-being, NYHA classification, and functional mitral regurgitation Reduction in heart failure hospitalizations MRI Safety Information The system remains MR Conditional when an Abbott Medical port plug is placed into an unused port of the MR Conditional device's header. Other accessories have not been tested in an MRI environment and their use in an MRI environment is not determined. Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. Data Security Abbott Medical takes a broad and deep approach to ensuring the safety, security and privacy of the patient information and data on our devices and systems connecting patients to healthcare providers and clinics. Patients, clinical staff, and hospital IT staff do not need to configure the pulse generator or take any special action, for example firewall use, to safeguard patient information and device data. The following safeguards are provided:

To prevent unauthorized data access, the pulse generator encrypts wireless communication. To prevent unauthorized data changes, the pulse generator limits communication to authorized devices. 9 To prevent unauthorized device access that could lead to premature battery depletion, the pulse generator disables Bluetooth communication after excessive usage. The programmer displays an alert after this occurs and automatically re-enables Bluetooth communication. All safeguards for the devices will be provided throughout the stated warranty period or until a replacement product is available. In the rare event that the cybersecurity is compromised on the pulse generator, high voltage therapy will continue to be available to the patient, and the device will operate in the hardware backup mode. For details on this mode refer to the Bradycardia and Tachycardia Devices Help Manual. The cybersecurity bill of materials (CBOM) is available upon request. Bluetooth Communication The pulse generator uses BLE with authentication methods to enable use with only applicable Abbott Medical authorized products. In the event of excessive BLE usage, which is an indicator of a possible attack on the pulse generator battery, BLE communication is turned off. The programmer will read the BLE shut-off during a clinic visit. You may choose to alert the patient of this occurrence. Inductive Communication Inductive Communication is a short-range communication channel that protects patient information by the proximity of the telemetry wand to the device. Only authorized healthcare providers should place the inductive wand over the device. 10 Warnings Implantation Procedure The physician should be familiar with all components of the system and the material in this manual, and with the sterile pulse generator implant procedure. The physician should also be familiar with follow-up evaluation and management of patients with an ICD or CRT-D before beginning the procedure. If not, the physician should refer the patient to such a physician. Ensure that an external defibrillator is immediately available during implant, electrophysiology testing, or MRI scan. Device Replacement Replace the pulse generator within three months of reaching ERI. Replace the pulse generator immediately upon reaching ERI if there is frequent high-voltage charging or one or more of the pacing outputs are programmed above 2.5 V. See Battery Information (page 57). Battery Incineration Do not incinerate pulse generators as they contain sealed chemical power cells and capacitors that may explode. Return explanted devices to Abbott Medical. Storage and Handling Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia therapies Off during surgical implant and explant or post-mortem procedures, and when disconnecting leads. The device can deliver a serious shock if you touch the defibrillation terminals while the device is charged. 11 High-Voltage Pulse Generator Perform all defibrillation testing with the pulse generator in the pocket. Magnetic Resonance Imaging (MRI) Certain accessories are untested, and their use in an MRI environment is not determined. See MRI Safety Information (page 9). Precautions Implantation Procedure Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it. Device Modification This device has been tested for compliance to FCC regulations. Changes or modifications of any kind not expressly approved by Abbott Medical could void the user's authority to operate this device. Storage and Handling Store the pulse generator between 59 and 86F (15C and 30C). During transportation and handling the pulse generator can be safely exposed to temperatures between -4F and 140F (20C and 60C). Storage outside of this range may result in device reset. 12 Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference to avoid device damage. Do not implant a device that has been dropped on a hard surface while outside of its intact shelf package, or from a height of more than 24 inches (61 cm) while within its intact shelf package. Sterility, integrity, or function cannot be guaranteed under these conditions, and the device should be returned to Abbott Medical for inspection. Temperature Equilibrium After cold storage, allow the device to reach room temperature before charging the capacitors, programming, or implanting the device because cold temperature may affect initial device function. Lead Impedance Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 or the lead impedance of chronic leads is less than 15 . Damage to the device may result if high-voltage therapy is delivered into an impedance less than 15 . Suboptimal Bluetooth Communication Below is a list of potential causes to suboptimal Bluetooth communication. 13 Table 5. Possible causes and solutions for suboptimal BLE communication Possible Causes Solutions The programmer or BLE dongle

(if available) orientation or location is suboptimal. People or objects interfere with the communication between the programmer and the device. The programmer or BLE dongle

(if available) is too far away from the device. Other products in the vicinity are causing electromagnetic interference (EMI). Move or reorient the programmer slightly. If available, ensure that the BLE dongle faces the implantable device. Make sure that the space between the programmer and the device is free from interfering objects or people. Move the programmer closer to the device. Power off or remove equipment that could cause EMI. NOTE: During initial interrogation or in-clinic operations such as clearing of diagnostics and trend data using wireless communication, a temporary loss of the marker channel and real-time EGM may occur. The system will automatically attempt to recover. To minimize disruption in wireless communication, move the programmer close to the device. If available ensure the BLE dongle faces the implantable device during in-

clinic sessions. 14 Disconnecting Leads and Avoiding Shock While Handling Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia therapies Off during surgical implant and explant or post-mortem procedures, and when disconnecting leads. The device can produce electrical artifacts that can be sensed by the pulse generator or deliver a serious shock if you touch the defibrillation terminals while the device is charged. If a programmer is not available, use a magnet to prevent delivery of tachyarrhythmia therapy in response to detected disconnection artifacts. Place the magnet over the pulse generator before disconnecting the leads. Do not remove it until the leads are reconnected. CAUTION: The Magnet Response parameter must be set to Normal for the magnet to prevent the delivery of tachyarrhythmia therapy. For more information, see Using a Magnet (page 44). External Equipment for Arrhythmia Induction If external equipment is used for arrhythmia induction through the pulse generator header and leads, apply rectified AC current through the high-voltage ports, not the sense/pace ports, to avoid damaging the sense/pace function. Disconnect the external equipment from the pulse generator before any therapy is delivered; otherwise, damage to the device is likely to occur. Place a magnet over the device until the external equipment can be disconnected. 15 Antiarrhythmic Drugs Antiarrhythmic drugs may alter the defibrillation energy threshold, rendering the pulse generator's countershock ineffective or causing the shock to induce a clinically significant arrhythmia. In addition, changing cardiac electrical characteristics may prevent detection of a tachyarrhythmia or may cause the pulse generator to misinterpret a normal rhythm as a clinically significant arrhythmia. Changes in medication may require defibrillation threshold testing, updating the morphology template, and reprogramming of the device. Sterilization The package contents have been sterilized with ethylene oxide before shipment. The device and accessories are FOR SINGLE USE ONLY and are not intended to be resterilized. Any attempt to resterilize and reuse may compromise the integrity of this system. Adverse effects associated with resterilization and reuse of components may include, but are not limited to:

Local or systemic infection Mechanical damage Inaccurate functionality Do not implant the device when the sterility indicator within the inner package is purple, because it might not have been sterilized, or when the storage package has been pierced or altered, because this could have rendered it nonsterile. Damaged Package Do not use the device or accessories if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to Abbott Medical. 16 Environmental Hazards External devices generating strong electromagnetic fields can cause operational problems in the pulse generator that include: cessation of or intermittent bradycardia pacing, and inadvertent antitachycardia pacing, cardioversion, or defibrillation. Additionally, high-energy induced or conducted currents can reset the programmed parameters and damage the pulse generator and tissue surrounding the implanted lead electrodes. Device Communication Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If the problem persists, contact Abbott Medical. Additional Pacemaker These devices provide bradycardia pacing. If another pacemaker is used, it should have a bipolar pacing reset mode and be programmed for bipolar pacing to minimize the possibility of the output pulses being detected by the device. External Defibrillators External defibrillation may damage the pulse generator. It may also result in temporary or permanent myocardial damage at the electrode-tissue interface or temporarily or permanently elevated pacing capture thresholds. Minimize current flowing through the pulse generator and lead system by following these precautions when using external defibrillation on a patient with a pulse generator:

Position defibrillator paddles as far from the pulse generator as possible (a minimum of 13 cm). Use the lowest clinically appropriate energy output. 17 Confirm the pulse generator is functioning following any external defibrillation. The effectiveness of external defibrillation may be reduced due to the insulating effect of the implanted defibrillation electrodes. Minimize this with proper external paddle placement relative to the orientation of the implanted defibrillation electrodes. Deliver the energy perpendicular to a line between the two implanted electrodes. External defibrillation may reprogram the device to its reset values. Assess any device parameter reset in conjunction with Abbott Medical Technical Support. Electrosurgical Instruments The pulse generator may detect electrocautery energy as cardiac events and deliver tachyarrhythmia therapy, induce ventricular arrhythmias or fibrillation, cause tissue damage near the implanted electrodes, damage the pulse generator, or reprogram the device to its reset values. Position the electrocautery ground electrode to minimize current flow through the implanted electrode system. Do not apply electrocautery directly to the pulse generator. During electrosurgery, disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia therapy Off. If a programmer is unavailable, use a magnet to inhibit delivery of tachyarrhythmia therapy. 18 Therapeutic Radiation Use devices emitting ionizing radiation with caution as they can cause damage to the CMOS circuitry in the pulse generator, which might not be immediately detectable. Devices such as linear accelerators, betatrons and cobalt machines can be used with proper therapeutic planning to minimize cumulative dosage levels to the pulse generator. Diagnostic Xrays, although a source of ionizing radiation, generally produce much lower levels and are not contraindicated. Consultation with clinical physicists and Abbott Medical is recommended. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage, and confirm the device is functioning after treatment. Hospital and Medical Environments High Radiation Sources Do not direct high radiation sources such as cobalt 60 or gamma radiation at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage, and confirm the device is functioning after treatment. Medical Lithotripsy Avoid lithotripsy unless the therapy site is not near the pulse generator and leads as lithotripsy may damage the pulse generator. Diathermy Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or permanently damage the pulse generator. 19 Ultrasound Therapy The device should not be exposed to therapeutic levels of ultrasound energy, as the device can inadvertently concentrate the ultrasound field and cause harm that might not be immediately detectable. Diagnostic ultrasound treatment is not known to affect the function of the device. Environmental and Medical Therapy Hazards Advise patients to avoid devices that generate a strong electric or magnetic interference (EMI). EMI could cause malfunction of or damage to the pulse generator, resulting in nondetection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation. Advise patients to avoid any areas marked with a No Pacer symbol. Home and Industrial Environments A variety of devices produce electromagnetic interference (EMI) of sufficient field strength and modulation characteristics to interfere with proper operation of the pulse generator. These include: high-

powered radio, television, and radar transmitters/antennas; high-voltage transmission lines; home appliances; arc or resistance welders; equipment with large motors; induction furnaces; very large or defective electric motors; and internal combustion engines with poorly shielded ignition systems. The patient should avoid strong magnetic fields since they are potentially capable of inhibiting tachyarrhythmia therapies. If a patient is frequently in a high-magnetic-field environment and therefore at risk of not having therapies delivered, you may choose to program the device to ignore magnetic fields. Therapies would then be delivered in the normal manner in response to detected arrhythmias. Magnet application would have no effect on operation. 20 Advise patients to not play sports or engage in activities where there is a risk of repetitive blows to the implanted device area. Twiddler's Syndrome: Caution patients against manipulating the implanted device as it may result in lead damage or lead displacement. Transcutaneous Electrical Nerve Stimulation Transcutaneous Electrical Nerve Stimulation (TENS) may interfere with device function. To reduce interference, place the TENS electrodes close to one another and as far away from the device/lead system as possible. Monitor cardiac activity during TENS use. Radiofrequency Ablation Radiofrequency ablation in a patient with a pulse generator may cause malfunction or damage. Minimize radiofrequency ablation risks by:

Programming all tachyarrhythmia therapies off Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator Positioning the groundplate so that the current pathway does not pass near the pulse generator. For example, place the groundplate under the patient's buttocks or legs Having external defibrillation equipment available 21 Electronic Article Surveillance (EAS) Advise patients that Electronic Article Surveillance/Anti-theft (EAS) systems such as those at the point of sale and entrances/exits of stores, libraries, and banks; or tag readers that include radio frequency identification (RFID) equipment such as those used for access control, asset tracking, animal identification, and vehicle immobilizers, emit signals that may interact with the device and cause abnormal pacing or inappropriate shock and pain. To minimize the possibility of interaction, advise patients to simply walk through these areas at a normal pace and avoid lingering near or leaning on these systems. Metal Detectors Advise patients that metal detector security systems such as those found in airports and government buildings emit signals that may interact with ICDs and CRTDs. To minimize the possibility of interaction, advise patients to simply walk through these areas at a normal pace and avoid lingering. Even so, the ICD and CRTD systems contain metal that may set off the airport security system alarm. If the alarm does sound, the patient should present security personnel with their patient identification card. If security personnel perform a search with a handheld wand, the patient should ask that they perform the search quickly, stressing that they should avoid holding the wand over the device for a prolonged period. Cellular Phones The pulse generator has been tested for compatibility with handheld wireless transmitters in accordance with the requirements of ISO 14117. This testing covered the operating frequencies 385 MHz - 3 GHz, and pulsed modulation techniques of all digital cellular phone technologies in worldwide use today. Based on the results of this testing, the normal operation of cellular phones should not affect the pulse generator. 22 Advise patients to not carry a cellular phone in a breast pocket or attach one to a belt if they are over the pulse generator. Some accessories for cellular phones may contain magnets, such as cases with magnetic clasps, which may cause the pulse generator to inhibit tachyarrhythmia therapy. Adverse Events The physician should discuss the patient's potential adverse events with the patient. Possible adverse events associated with the implantation of the pulse generator system include the following:

Arrhythmia (for example, accelerated or induced) Bradycardia Cardiac or venous perforation Cardiac tamponade Cardiogenic shock Death Discomfort Embolism Endocarditis Erosion Exacerbation of heart failure Excessive fibrotic tissue growth Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle) Extrusion 23 Fluid accumulation within the device pocket Formation of hematomas, cysts, or seromas Heart block Hemorrhage Hemothorax Hypersensitivity, including local tissue reaction or allergic reaction Infection Keloid formation Myocardial damage Nerve damage Occlusion/Thrombus Pericardial effusion Pericarditis Pneumothorax Pulmonary edema Syncope Thrombosis Valve damage 24 Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following:

Abnormal battery depletion Conductor fracture Device-programmer communication failure Elevated or rise in defibrillation/cardioversion threshold Inability to defibrillate or pace Inability to interrogate or program due to programmer or device malfunction Incomplete lead connection with pulse generator Inhibited therapy including defibrillation and pacing Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing) Interruption of function due to electrical or magnetic interference Intolerance to high rate pacing (for example dyspnea or discomfort) Lead abrasion Lead fracture Lead insulation damage 25 Lead migration or lead dislodgement Loss of device functionality due to component failure Pulse generator migration Rise in DFT threshold Rise in pacing threshold and exit block Shunting of energy from defibrillation paddles System failure due to ionizing radiation Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following:

Allergic reaction to contrast media Breakage or failure of implant instruments Prolonged exposure to fluoroscopic radiation Renal failure from contrast media used to visualize coronary veins Pulse Generator Header The pulse generator headers are shown below and the legend for the lead receptacles are described in the table (page 30) below. 26 Table 6. Single-chamber ICD headers (see table (page 30) for legend) Avant VR CDVRA700Q Neutrino NxT VR CDVRA800Q Neutrino NxT VR CDVRA600Q Gallant VR CDVRA500Q Entrant VR CDVRA300Q Table 7. Single-chamber ICD headers (see table (page 30) for legend) Avant VR CDVRA700T Neutrino NxT VR CDVRA800T Neutrino NxT VR CDVRA600T Gallant VR CDVRA500T Entrant VR CDVRA300T 27 Table 8. Dual-chamber ICD headers (see table (page 30) for legend) Avant DR CDDRA700Q Neutrino NxT DR CDDRA800Q Neutrino NxT DR CDDRA600Q Gallant DR CDDRA500Q Entrant DR CDDRA300Q Table 9. Dual-chamber ICD headers (see table (page 30) for legend) Avant DR CDDRA700T Neutrino NxT DR CDDRA800T Neutrino NxT DR CDDRA600T Gallant DR CDDRA500T Entrant DR CDDRA300T 28 Table 10. CRT-D headers (see table (page 30) for legend) Avant HF CDHFA700Q Neutrino NxT HF CDHFA800Q Neutrino NxT HF CDHFA600Q Gallant HF CDHFA500Q Entrant HF CDHFA300Q Table 11. CRT-D headers (see table (page 30) for legend) Avant HF CDHFA700T Neutrino NxT HF CDHFA800T Neutrino NxT HF CDHFA600T Gallant HF CDHFA500T Entrant HF CDHFA300T 29 Lead Receptacle Connector Types Table 12. Lead receptacles Legend Number Receptacle Lead type Connector 1 2 3 4 5 6 RA, IS-1 Bi RV, DF4-LLHH LV, IS4-LLLL SVC, DF-1 RV, DF-1 RV, IS-1 Bi Bipolar endocardial; IS1 plug (when no atrial lead is used) IS1 inline bipolar Defibrillation and bipolar endocardial DF4LLHH Four electrode, bipolar left ventricle IS4LLLL Defibrillation Defibrillation DF-1 DF-1 Bipolar endocardial IS-1 in-line bipolar IS-1 connector cavities comply with ISO 5841-3. DF4 and IS4 connector cavities comply with ISO 27186. DF-1 connector cavities comply with ISO 11318. 30 NOTE: When connecting leads to the pulse generator, make sure that you plug the correct lead into the correct lead receptacle. For sensing and pacing, this is important to ensure that atrial and ventricular signals are correctly recorded and that pacing pulses are delivered in the desired chamber. The DF4LLHH lead receptacle can only be used with DF4LLHH leads that combine the RV and SVC defibrillation coils and the RV sense/pace electrode into a single connector. The IS4LLLL lead receptacle can only be used with IS4LLLL left heart leads. The DF-1 Lead receptacle can only be used with RV (RV coil) DF-1 or SVC (SVC coil) DF-1 leads. (Make sure that each DF-1 lead is plug into the corresponding RV or SVC individual lead connector). The IS-1 lead receptacle can only be used with RA IS-1 Bipolar or RV IS-1 Bipolar sensing/pacing leads.

(Make sure that each IS-1 lead is plug into the corresponding RA or RV individual lead connector, if available). When a single coil DF-1 defibrillation lead is used, make sure that the DF-1 lead is inserted into the RV (RV coil) DF-1 connector. The DF-1 receptacle plug must be secured in the SVC port to make a complete defibrillation system. Do not use any lead with the pulse generator without first verifying lead and connector compatibility. 31 Figure 1. Nominal dimensions of DF4LLHH lead connector (mm) 1. 1. V Tip 2. 2. RV Ring 3. 3. RV Coil 4. 4. SVC Coil Figure 2. Nominal dimensions of IS4LLLL lead connector (mm) 1. 1. Distal Tip 1 2. 2. Mid 2 3. 3. Mid 3 4. 4. Proximal 4 Sensing The pulse generator has an Automatic Sensitivity Control feature to allow accurate sensing in both the atrium and the right ventricle over a wide range of signal strengths. NOTE: Ventricular sensing is done only in the right ventricle. 32 Table 13. Ranges for sensitivity settings Parameter Range Atrial Maximum Sensitivity 0.21.0 mV Ventricular Defibrillator Maximum Sensitivity Ventricular Pacemaker Maximum Sensitivity 0.21.0 mV 0.22.0 mV The Atrial Sensitivity setting of 0.2 mV may be more susceptible to EMI according to testing required by ISO 14117 clause 4.5.2. The devices comply with the electromagnetic compatibility requirements of ISO 14117 clause 4.5.2 at atrial sensitivity of 0.3 mV and less sensitive settings. For devices with the Low Frequency Attenuation Filter ON, Ventricular Sensitivity of 0.3 mV and 0.4 mV may be more susceptible to EMI according to testing required by ISO 14117 clause 4.5.2.The devices comply with the electromagnetic compatibility requirements of ISO 14117 clause 4.5.2 ventricular sensitivities of 0.5 mV and less sensitive settings. For devices with the Low Frequency Attenuation Filter OFF, Ventricular Sensitivity of 0.3 mV may be more susceptible to EMI according to testing required by ISO 14117 clause 4.5.2. The devices comply with the electromagnetic compatibility requirements of ISO 14117 clause 4.5.2 at atrial and ventricular sensitivities of 0.3 mV and less sensitive settings. Radiopaque Identification Each pulse generator has an Xray absorptive marker for noninvasive identification. The marker consists of the Abbott symbol (A), and a two-letter model code. 33 Table 14. Xray ID codes for the device models described in this manual Device Model Xray ID Model Code KM CDVRA300Q, CDVRA500Q, CDVRA600Q, CDVRA700Q, CDVRA800Q CDVRA300T, CDVRA500T, CDVRA600T, CDVRA700T, CDVRA800T CDDRA300Q, CDDRA500Q, CDDRA600Q, CDDRA700Q, CDDRA800Q CDDRA300T, CDDRA500T, CDDRA600T, CDDRA700T, CDDRA800T CDHFA300Q, CDHFA500Q, CDHFA600Q, CDHFA700Q, CDHFA800Q CDHFA300T, CDHFA500T, CDHFA600T, CDHFA700T, CDHFA800T 34 Implanting the Pulse Generator Training Personnel Physicians should be familiar with all components of the system and the contents of this manual before beginning the procedure. Abbott Medical provides physicians with comprehensive, on-site training and support. Physicians and support staff also receive training in follow-up and patient management. Inspecting and Handling the Device Inspect the packaging before removing the device. Do not implant the pulse generator if:

The package is damaged or wet The dot on the ethylene oxide label is purple Purple indicates that the package may not been sterilized. The Use Before Date on the outer box and the tray has been exceeded The Use Before Date reflects the minimum battery capacity required to support the calculated battery longevity shown in the programmer's on-screen help. The pulse generator has been sterilized using ethylene oxide gas. If the sterile package has been compromised, return the device to Abbott Medical. CAUTION: The device is for single use only and is not intended to be resterilized. CAUTION: Do not submerge pulse generators in liquids or liquid baths. CAUTION: The pulse generator should not be autoclaved, immersed in sterilant liquids, gamma-

irradiated, or ultrasonically cleaned. 35 Sterile Package and Contents The pulse generator is supplied in a sterile tray for introduction into the operating field. The tray contains:

One pulse generator (with all therapies off) with pre-installed setscrews One torque wrench The outer box contains:

Literature The non-pyrogenic label is applicable to the pulse generator only, and is not applicable to any other component contained in the device package. Opening the Sterile Package To open the package and remove the pulse generator:

1. Peel back the outer tray cover, starting with the corner labeled with an arrow. 1. 2. 2. Observing sterile technique, lift up the end of the inner tray that rests in the recess in the outer tray. 3. Peel off the inner tray cover, starting with the corner labeled with an arrow. 3. 4. 4. Use the recessed areas to facilitate removing the pulse generator and accessories from the tray. Choosing the Implant Site The pulse generator can be implanted in either the pectoral region or the abdominal region, at the physician's discretion. 36 Pectoral Placement Before deciding to implant the pulse generator pectorally, assess patients on a case-by-case basis to ensure their suitability for pectoral implantation. If the device is implanted pectorally, a single incision may be used to form the pocket and provide access for transvenous lead placement. Use short leads of appropriate length to avoid the necessity of coiling extra lead length in the pocket. Submuscular For access to the cephalic and subclavian veins, make a single incision over the delta-pectoral groove. To avoid interfering with left shoulder motion, place the pulse generator medial to the humeral head. Subcutaneous For access to the cephalic vein, make a long, transverse incision. To ensure that the leads are far enough from the axilla, place the device as far medially as possible. Place the device in the pocket so that the upper edge is inferior to the incision. To prevent migration, anchor the device to the pectoral muscle using the suture holes in the device header. Abdominal Placement Abdominal placement is recommended for patients who have had previous pectoral surgery or for whom the physician decides that pectoral placement is undesirable for anatomical reasons. Use leads longer than 75 cm with devices implanted abdominally. 37 Implanting the Leads and Testing the Device Forming the Pocket and Connecting the Leads 1. 1. If it has not already been done, prepare a pocket for the pulse generator. WARNING: To avoid any risk of accidental shock, make sure that tachyarrhythmia therapies are off before handling the pulse generator. Do not program the pulse generator on until it is inserted in the pocket. CAUTION: Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it. 2. 2. Insert the lead pins into their receptacles, past the setscrew opening. If necessary, use sterile lubricant on the insulated shoulder of the lead connectors. Properly inserted, the plug heads protrude only a few millimeters from the header. Do not use forceps or other tools to insert the plug as these can damage its silicone insulation. CAUTION: Setscrews are installed in the pulse generator at the time it is shipped. Exercise caution when turning the setscrew, which may be backed out of the connector if turned counterclockwise for more than two rotations. NOTE: When connecting leads to the pulse generator, make sure that you plug the correct lead into the correct lead receptacle. For sensing and pacing, this is important to ensure that atrial and ventricular signals are correctly recorded and that pacing pulses are delivered in the desired chamber. WARNING: If you are using a single defibrillation lead with only one defibrillation coil, make sure that the lead is in the receptacle for the RV (DF1) lead. Lubricate and insert the DF1 plug into the 38 receptacle for the SVC (DF1) lead. If the lead is not in the RV receptacle, the can and the lead will have the same polarity and there will be no current flow. CAUTION: When the DF4LLHH lead receptacle is plugged, disable tachyarrhythmia therapy. NOTE: For IS4/DF4 leads and lead receptacles, do not use silicone oil, mineral oil, or any substance other than sterile saline, water, or heparinized saline as a lubricant. For IS1 leads and lead receptacles the use of a lubricant is optional. 3. Use and fasten the appropriate lead receptacle plug in an unused lead receptacle. Refer to Spare Parts 3. and Accessories (page 63) for a list of available lead receptacle plugs. For IS-1 and DF-1 leads and lead receptacles the use of a lubricant is optional. For dualchamber and CRTD devices, if you are not using an atrial sense/pace lead, lubricate and insert an IS1 receptacle plug into the receptacle for the atrial sense/pace lead. For CRTD devices, if you are not using a left ventricular pacing lead, lubricate and insert an IS1 plug into the receptacle for the LV lead. 4. 4. Carefully insert the tip of the torque wrench into the setscrew and turn the handle clockwise until you hear at least three clicks. Grip the torque wrench by the large part of the handle as shown in the figure on the left below. On applicable models, do not grip the torque wrench by the smaller, narrower part of the handle as shown on the right. 39 Figure 3. Correct vs. incorrect use of torque wrench 5. 5. Coil any excess lead length underneath the pulse generator in the implant pocket. After implanting the leads, test the lead systems. Because of the difference in capacitance between the pulse generator and an external stimulation device, we strongly recommend device-based testing. However, you may want to use a single, initial test using an external stimulation device to screen for patients with a high defibrillation threshold before you open the pulse generator package. Patient Notifier. Before setting Patient Notifier On, use the Test Notifier button to test the Patient Notifier feature. The test initiates the sound produced during Patient Notifier Delivery to ensure the patient is aware of the tone emitted by the Patient Notifier. The test can be cancelled at any time. 40 NOTE: The myMerlinPulse patient app indicates when the Patient Notifier was triggered. You should discuss specific Patient Notifier follow-up instructions with the patient. See Patient Education for more information (page 41). Managing and Following Patients Patient Education Abbott Medical provides a booklet for patients to explain the device and its operation in addition to a patient manual to explain the myMerlinPulse mobile application. You can use these to supplement your discussions with the patient, and spouse or other interested persons. To obtain other available patient education materials, contact Abbott Medical. Patient Registration Form Fill out and return the Patient Registration Form to register the patient and facilitate patient tracking. Patient Identification Card Fill out the Patient Identification Card as provided in the outer box with the patients name, implant date, and your name or healthcare facility information along with the contact phone number. Record device information

(model number, serial number, and UDI number), and implanted leads information (model and length), or apply the labels provided with the sterile package, in the designated section of the card. Fill out the location of the device and leads in the corresponding location fields on the Patient Identification Card. Give the completed card to the patient. This will serve as a temporary card until Abbott Medical mails a permanent card directly to the patient. To obtain a replacement card if a patient loses or damages their card, contact Abbott Medical Technical Support. 41 Patient Follow-Up Patients who receive a pulse generator should be seen for follow-up every three months. If the patient experiences a spontaneous episode, it may be deemed appropriate for the patient to return for follow-up immediately. A follow-up visit should include (at a minimum):

Review of the FastPath Summary screen Review of stored and real-time EGMs Review of morphology template performance (if applicable) Review of sensing amplitude and pacing thresholds Confirmation that the final parameter settings are correct Progression or changes over time in the patient's underlying heart or systemic disease may necessitate a re-

evaluation of the patient's clinical arrhythmias and reprogramming of device detection and therapy parameters. Stored EGMs obtained during followup visits can help determine when to return to the electrophysiology laboratory, as in the case of an observed change in the VT rate. Device settings should be re-evaluated if the patient's antiarrhythmic medication is changed. Depending on clinical circumstances and the patient's level of understanding, it may be advisable to give the patient a magnet for emergency use. The delivery of a high-voltage shock into a damaged lead system may result in device failure, including the inability to deliver therapy or pace, inappropriate shocks, and/or premature battery depletion. Carefully monitor the lead system integrity during patient follow-up for insulation damage or fractures which may result in secondary device failure due to the arcing of current back to the device can. 42 Device Longevity For estimated longevity calculations, see the programmer's on-screen help. Elective Replacement Indicator (ERI) The programmer displays the remaining capacity to ERI percentage to help the clinician determine whether a pulse generator should be replaced. Check these figures at each follow-up visit. Immediately following a high-voltage charge, the battery capacity may be much lower than its normal value. Normal Battery Condition Battery capacity of more than ERI indicates that the device is not currently in need of replacement and that it will operate according to the specifications listed in this manual. ERI to EOS Battery Condition The pulse generator will continue to operate according to specifications in the ERI to end of service (EOS) range, except for the following:

Pacing amplitude and high-voltage charge time is changed ATP during charging is disabled CRT-Ds with MPP capability only: MPP is disabled Careful monitoring of the battery status is strongly advised until the pulse generator can be replaced. WARNING: Replace the pulse generator within three months of reaching the ERI indication. (This assumes that regular follow-up visits occur every three months, thereby taking into account the possibility that the battery reached the ERI level sometime in the previous three months and still has approximately three months remaining at this battery level). Replace the pulse generator immediately 43 after it reaches ERI if there is frequent high-voltage charging or one or more of the pacing outputs are programmed above 2.5 V. Past EOS Battery Condition The programmer displays an EOS battery alert to indicate that the pulse generator should be replaced immediately. Below the EOS value, the pulse generator will continue to function, but some operating parameters will be out of specification. Pacing lead impedance may read higher than actual, and the 2.5 V pacing setting is no longer regulated. High-voltage charge times will be extended. If the capacitors take longer than 28 s to reach the programmed voltage, charging stops and the pulse generator delivers whatever voltage is present on the capacitors. When the battery capacity drops below EOS the pulse generator could oversense; therefore, some device functions are automatically disabled, including ATP, arrhythmia induction, and capture testing. There is no guarantee that the pulse generator will deliver a high-voltage shock after the EOS condition is detected on the battery. Using a Magnet The pulse generator contains a magnet sensor that when activated prevents delivery of tachyarrhythmia therapy. When the magnet is in place and the magnet response is set to Normal, an auditory tone will be present for 4 seconds. If a tone is not detected, the magnet should be moved or another magnet should be tried. When the magnet is removed, a higher audible tone will be present for 6 seconds once tachyarrhythmia detection has been restored. When the magnet response is set to Ignore the device ignores the presence of a magnet and delivers therapy as usual. 44 Bradycardia pacing is not affected by a magnet placed over a pulse generator. CAUTION: The magnet is for temporary inhibition of tachyarrhythmia therapy. If inhibition is required for longer than eight hours, disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia therapy Off. The presence of both a magnet and the programming wand near the implanted device may interfere with telemetry and cause a loss of communication with the programmer. If you need to communicate with the device and use a magnet simultaneously (for example, to confirm proper magnet placement by telemetry), first position the magnet over the device and then place the wand over the device. If the magnet is brought close to the device while communication is already in progress, the programmer may, in rare cases, not detect the presence of the magnet and a device reset may occur. Explanting the Pulse Generator WARNING: Before explanting the system or disconnecting the leads from a pulse generator, disable Tachy Therapy or program the pulse generator to tachyarrhythmia therapy Off. In the event of the patient's death, deactivate the pulse generator before post-mortem examination. Explant the device with standard surgical tools. If a lead or adapter is explanted, be careful not to damage it during removal. Before returning the explanted pulse generator to Abbott Medical, clean it with disinfectant solution, but do not submerge it. Fluid in the lead receptacles of the pulse generator or adapter impedes analysis of the product. 45 WARNING: Pulse generators contain sealed chemical power cells and capacitors and therefore should never be incinerated. Out-of-Service/Explant/Patient Death Form Whenever a pulse generator is explanted, or if any of the leads or adapters are replaced or capped, complete an OutofService/Explant/Patient Death form and return it to Abbott Medical with the explanted products. If possible, send along a printout of the programmed settings of the pulse generator. For information on printing reports, see the appropriate reference manual. Technical Support Abbott Medical maintains 24-hour phone lines for technical questions and support:

1 818 362 6822 1 800 722 3774 (toll-free within North America)

+ 46 8 474 4147 (Sweden)

+ 61 2 9936 1200 (Australia) medical.abbott/manuals For additional assistance, call your local Abbott Medical representative. Any serious incident should be reported to Abbott Medical and the FDA. Additional Information For additional information on this device, see the programmer's on-screen help. This device is designed to reliably install firmware patches without disrupting patient therapy. 46 If you need assistance installing firmware for this device, contact Technical Support. High-Voltage Waveforms Table 15. Highvoltage waveforms 1 for 36 J devices Energy Setting Max 31.7 31.7 844 844 Monophasic Delivered pulse energy (J)

(first shock) Delivered pulse energy (J)

(sequential shock) Peak ICD output voltage

(V) (first shock) Peak ICD output voltage

(V) (sequential shock) Biphasic Delivered pulse energy (J)

(first shock) First phase 31.3 1 Monophasic and biphasic waveforms at 65% fixed tilt. Min 0.1 0.1 47.8 47.8 0.1 47 Mean 17 17 626.5 626.5 15 Table 15. Highvoltage waveforms for 36 J devices Energy Setting Max Second phase 4.4 Delivered pulse energy (J)

(sequential shock) First phase Second phase Peak ICD output voltage

(V) (first shock) First phase Second phase Peak ICD output voltage

(V) (sequential shock) First phase Second phase 31.3 4.4 846.6 298.9 846.6 298.9 Min 0.04 0.1 0.04 44 15 44 15 48 Mean 2.1 15 2.1 592.1 210.4 592.1 210.4 Table 16. Highvoltage waveforms 2 for 40 J devices Energy Setting Max 32.8 36.2 846.4 887.8 Monophasic Delivered pulse energy (J)

(first shock) Delivered pulse energy (J)

(sequential shock) Peak ICD output voltage

(V) (first shock) Peak ICD output voltage

(V) (sequential shock) Biphasic Delivered pulse energy (J)

(first shock) First phase Second phase 32.8 4.4 2 Monophasic and biphasic waveforms at 65% fixed tilt. Min 0.1 0.1 61 61 0.1 0.0004 49 Mean 20 20 670.1 670.1 17.7 2.4 Table 16. Highvoltage waveforms for 40 J devices Energy Setting Max Min Mean Delivered pulse energy (J)

(sequential shock) First phase Second phase Peak ICD output voltage

(V) (first shock) First phase Second phase Peak ICD output voltage

(V) (sequential shock) First phase Second phase 36.4 5 848.5 296.8 893.8 313.6 17.7 2.4 632.5 225.2 632.5 225.2 0.1 0.0004 39.4 9.9 39.4 9.9 50 Physical Specifications Device Measurements Table 17. Device measurements, single-chamber ICDs Model Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) CDVRA300Q 63 X 51 X 12 CDVRA500Q 63 X 51 X 12 CDVRA600Q 63 X 51 X 12 CDVRA700Q 63 X 51 X 12 CDVRA800Q 63 X 51 X 12 69 69 69 69 69 30 30 30 30 30 39 45 45 45 45 Table 18. Device measurements, single-chamber ICDs Model CDVRA300T CDVRA500T CDVRA600T Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) 73 X 51 X 14 73 X 51 X 14 73 X 51 X 14 72 72 72 35 35 35 39 45 45 51 Table 18. Device measurements, single-chamber ICDs Model CDVRA700T CDVRA800T Dimensions

(l x w x h) (mm) 73 X 51 X 14 73 X 51 X 14 Weight (g) 72 72 Displaced volume

(cm) Stored energy (J) 35 35 45 45 Table 19. Device measurements, dualchamber ICDs Model Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) CDDRA300Q 69 x 51 x 12 CDDRA500Q 69 x 51 x 12 CDDRA600Q 69 x 51 x 12 CDDRA700Q 69 x 51 x 12 CDDRA800Q 69 x 51 x 12 71 71 71 71 71 Table 20. Device measurements, dualchamber ICDs 31 31 31 31 31 39 45 45 45 45 Model Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) CDDRA300T 73 x 51 x 14 72 35 39 52 Table 20. Device measurements, dualchamber ICDs Model CDDRA500T CDDRA600T CDDRA700T CDDRA800T Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) 73 x 51 x 14 73 x 51 x 14 73 x 51 x 14 73 x 51 x 14 72 72 72 72 35 35 35 35 45 45 45 45 Table 21. Device measurements, CRT-Ds Model Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) CDHFA300Q 74 x 51 x 12 CDHFA500Q 74 x 51 x 12 CDHFA600Q 74 x 51 x 12 CDHFA700Q 74 x 51 x 12 CDHFA800Q 74 x 51 x 12 76 76 76 76 76 34 34 34 34 34 39 45 45 45 45 53 Table 22. Device measurements, CRT-Ds DF-1 Model CDHFA300T CDHFA500T CDHFA600T CDHFA700T CDHFA800T Dimensions

(l x w x h) (mm) Weight (g) Displaced volume

(cm) Stored energy (J) 79 x 51 x 14 79 x 51 x 14 79 x 51 x 14 79 x 51 x 14 79 x 51 x 14 77 77 77 77 77 37 37 37 37 37 39 45 45 45 45 Device Materials Table 23. Device Materials Model All devices Can Titanium BLE antenna 3 Header Titanium Elasthane and Epoxy Septum Silicone 3 For devices with BLE telemetry capability. 54 Noise Detection Table 24. Noise detection Model All devices Noise Detection Rate 100 or more sensed events per second Charge Time Table 25. Charge Time Model All devices at beginning of service (at first shock) Lead Compatibility Lead compatibility Device Singlechamber ICDs

(DF4LLHH) Single-chamber ICDs

(DF-1) Charge Time Less than 9 seconds Lead compatibility High voltage and RV low voltage: one DF4LLHH lead connector High voltage: two DF1 3.2 mm lead (SVC and RV) connectors. 55 Lead compatibility Device Dualchamber ICDs

(DF4LLHH, IS1) Dualchamber ICDs

(DF-1, IS1) CRTDs

(IS1, DF4LLHH, IS4LLLL) CRTDs

(DF-1, IS-1, IS4-LLLL) Lead compatibility RV low voltage: one IS1 3.2 mm bipolar lead connector High voltage and RV low voltage: one DF4LLHH lead connector. RA low voltage: one IS1 3.2 mm bipolar lead High voltage: two DF1 3.2 mm lead (SVC and RV) connectors RV low voltage: one IS1 3.2 mm bipolar lead connector RA low voltage: one IS1 3.2 mm bipolar lead connector High voltage and RV low voltage: one DF4LLHH lead connector RA low voltage: one IS1 3.2 mm bipolar lead LV low voltage: one IS4LLLL lead connector (LV) lead High voltage: two DF1 3.2 mm lead (SVC and RV) connectors. RV low voltage: one IS1 3.2 mm bipolar lead connector 56 Lead compatibility Device Lead compatibility RA low voltage: one IS1 3.2 mm bipolar lead connector LV low voltage: one IS4LLLL lead connector (LV) lead WARNING: Do not use another manufacturer's lead system without demonstrated compatibility as undersensing cardiac activity, and failure to deliver necessary therapy may result. Battery Information Table 26. Battery information Device Battery information is applicable to all device models Battery chemistry;

Manufacturer; Model; Cells Silver vanadium oxide/carbon monofluoride;

Greatbatch Medical;

Model 3451; One cell 57 Device Configurations Table 27. Device configuration, single-chamber ICDs Single-chamber ICDs Tachyarrhythmia Configuration Bradyarrhythmia Mode Defibrillator with No Tachycardia Response (1 Zone: VF);

Defibrillator with Tachycardia Response - Single Tachycardia Discrimination

(2 Zones: VT, VF);

Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT1, VT2, VF);

Off VVI(R), Pacer Off;

Additional modes available in the tachyarrhythmia therapy Off configuration:

VOO;

Additional modes available as temporary modes: VOO SVT Discrimination Mode 4 Ventricular Only V Pulse & Sense Configuration Bipolar (RVtip to RVring) 4 Sensing only in the right ventricle. 58 Table 28. Device configuration, dual-chamber ICDs Dual-chamber ICDs Tachyarrhythmia Configuration Bradyarrhythmia Mode 5 Defibrillator with No Tachycardia Response (1 Zone: VF);

Defibrillator with Tachycardia Response - Single Tachycardia Discrimination

(2 Zones: VT, VF);

Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT1, VT2, VF);

Off AAI(R), VVI(R), VVT(R), DDI(R), DDD(R), DDT(R), Pacer Off;

Additional modes available in the tachyarrhythmia therapy Off configuration:

AOO, VOO, DOO;

Additional modes available as temporary modes: AOO, VOO, DOO, AAT SVT Discrimination Mode 6 Ventricular Only, Dual Chamber A Pulse & Sense Configuration Bipolar (Atip to Aring) V Pulse & Sense Configuration Bipolar (RVtip to RVring) 5 VVT(R) and DDT(R) modes are available in devices with Ventricular Triggering Capability. See the programmer's online help for a complete list. 6 Sensing only in the right atrium and right ventricle. 59 Table 29. Device configuration, CRTDs with quadripolar lead support CRTDs with IS4 Lead Capability Tachyarrhythmia Configuration Bradyarrhythmia Mode 7 Defibrillator with No Tachycardia Response (1 Zone: VF);

Defibrillator with Tachycardia Response - Single Tachycardia Discrimination

(2 Zones: VT, VF);

Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT1, VT2, VF);

Off AAI(R), VVI(R), VVT(R), DDI(R), DDD(R), DDT(R), Pacer Off;

Additional modes available in the tachyarrhythmia therapy Off configuration:

AOO, VOO, DOO;

Additional modes available as temporary modes: AOO, VOO, DOO, AAT SVT Discrimination Mode 8 Ventricular Only, Dual Chamber A Pulse & Sense Configuration Bipolar (Atip to Aring) RV Pulse & Sense Configuration Bipolar (RVtip to RVring) 7 VVT(R) and DDT(R) modes are available in devices with Ventricular Triggering Capability. See the programmer's online help for a complete list. 8 Sensing only in the right atrium and right ventricle. 60 Table 29. Device configuration, CRTDs with quadripolar lead support LV Pulse Configuration CRTDs with IS4 Lead Capability Distal tip 1-Mid 2;

Distal tip 1-Mid 3;

Distal tip 1-Proximal 4;

Distal tip 1-RV Coil;

Mid 2-Mid 3;

Mid 2-Proximal 4; Mid 2-RV Coil;

Mid 3-Mid 2;

Mid 3-Proximal 4;

Mid 3-RV Coil;

Proximal 4-Mid 2;

Proximal 4-Mid 3;

Proximal 4-RV Coil Runaway Protection Hardware circuitry in the pulse generator prevents the device from stimulating at rates higher than runaway protection rate, which is 210 min (5 min). 61 Inductive Communication While you are conducting the Fibber and NIPS tests using inductive telemetry, ensure that the telemetry wand is at least 2 cm away from and centered over the device. Charging while the telemetry wand is too close may result in a loss of communication when the device charges or dumps the capacitor. If this occurs, the test ends and the device returns to the permanently programmed parameters. BLE Operating Frequencies Nearby equipment emitting strong magnetic fields can interfere with BLE communication, even if the other equipment complies with CISPR emission requirements. The operating characteristics are as follows:

Bluetooth Low Energy wireless communication operates:

At 2.402 to 2.4835 GHz at 1 megabits/s Over a short range (within 2.5 meters in normal use) The effective radiated power is below the limits as specified in:

Europe: EU EN 300 328 USA: FCC Part 15 Subpart C paragraph 15.247 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 62 Spare Parts and Accessories Only the accessories listed here are approved for use with the pulse generators described in this manual. Table 30. Spare parts and accessories Model Number 4422 AC0130 424 3111 ACIP2 ACIS4PP AC-DP-3 Name/Description Torque wrench Silicone oil Medical adhesive Magnet IS1 receptacle plug 9 IS4/DF4 port plug DF1 receptacle plug Detection Performance in the Presence of Electromagnetic Interference in Differential Mode For ICD devices (VR and DR), The Atrial Sensitivity setting of 0.2mV and Ventricular sensitivity of 0.3mV (Low Frequency Attenuation Filter ON) may be more susceptible to EMI (as defined by ISO 14117 clause 4.5.2). 9 Dual-chamber ICDs and CRTDs only. 63 Atrial Sensitivity of 0.3mV (and less sensitive settings) and Ventricular Sensitivity of 0.4 mV and less sensitive settings (Low Frequency Attenuation Filter On) comply with the requirements of ISO 14117 clause 4.5.2, which requires that the implantable pulse generator shall be constructed so that commonly encountered electromagnetic signals are unlikely to be confused with sensed beats and change the therapeutic behavior of the implantable pulse generator. For CRT-D devices, The Atrial Sensitivity setting of 0.2mV and Ventricular sensitivity of 0.3mV (Low Frequency Attenuation Filter ON) may be more susceptible to EMI (as defined by ISO 14117 clause 4.5.2). Atrial Sensitivity of 0.3mV (and less sensitive settings) and Ventricular Sensitivity of 0.3mV (Low Frequency Attenuation Filter OFF) and less sensitive settings comply with the requirements of ISO 14117 clause 4.5.2, which requires that the implantable pulse generator shall be constructed so that commonly encountered electromagnetic signals are unlikely to be confused with sensed beats and change the therapeutic behavior of the implantable pulse generator. The common mode rejection ratio for this device for 16.6 Hz, 50 Hz and 60 Hz is higher than a factor of 100. 64 Figure 4. Detection performance in the presence of EMI in differential mode (with Low Frequency Attenuation Filter Off 10) 1. 1. Amplitude (V) 2. 2. Frequency (Hz) 3. 3. Detection Zone 4. 4. No Interference 5. 5. Right Ventricle (0.3 mV, Filter Off) 6. 6. Right Ventricle (0.3 mV, Filter On) 7. 7. Atrium (0.2 mV) 10 For devices with the Low Frequency Attenuation Filter only. 65 Figure 5. Detection performance in the presence of EMI in differential mode (with Low Frequency Attenuation Filter On 11) 1. 1. Amplitude (V) 2. 2. Frequency (Hz) 3. 3. Detection Zone 4. 4. No Interference 5. 5. Right Ventricle (0.3 mV) 6. 6. Right Ventricle (0.4 mV) 7. 7. Atrium (0.2 mV) 11 For devices with the Low Frequency Attenuation Filter only. 66 Symbols The symbols below and harmonized symbols may be found on the product or product label. For harmonized symbols, refer to the Universal Symbols Glossary at medical.abbott/manuals. Symbol Description VVED - DDDR Dual-chamber ICDs VVEV - VVIR Single-chamber ICDs VVED - DDDRV CRTDs LLHH LLLL NBD - NBG Code; NBD - ventricular shocking, ventricular antitachycardia pacing, electrogram detection, dual-chamber bradycardia pacing; NBG -

dual-chamber pacing, dual-chamber sensing, dual response, rate-modulated NBD - NBG Code; NBD - ventricular shocking, ventricular antitachycardia pacing, electrogram detection, ventricular bradycardia pacing; NBG -

ventricular pacing, ventricular sensing, inhibited response, rate-modulated NBD - NBG Code; NBD - ventricular shocking, ventricular antitachycardia pacing, electrogram detection, dual-chamber bradycardia pacing; NBG -

dual-chamber pacing, dual-chamber sensing, dual response, rate-modulated, biventricular pacing Quadripolar connector (low voltage, low voltage, high voltage, high voltage) Quadripolar connector (low voltage, low voltage, low voltage, low voltage) Shipped settings. The pulse generator is shipped with all functions off 67 Symbol Description Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM) This equipment is certified for type certification pursuant of Article 3824 of the Japan Radio Law Korea Certification mark for electrical devices This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Industry Canada certification Accessories Product literature 68 Symbol Description Manufacturing facility Importer RV, DF4-LLHH RV defibrillation port with quadripolar connector (low voltage, low voltage, high voltage, high voltage) RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; RV, DF4-LLHH RV defibrillation port with quadripolar connector (low voltage, low voltage, high voltage, high voltage) RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; LV, IS4-LLLL - LV pacing port with quadripolar connector (low voltage, low voltage, low voltage, low voltage); RV, DF4-LLHH RV defibrillation port with quadripolar connector (low voltage, low voltage, high voltage, high voltage) 69 Symbol Description SVC, DF-1 - SVC defibrillation port with DF-1 connector; RV, IS-1 Bi -

Ventricular pacing port with IS-1 bipolar connector; RV, DF-1 - RV defibrillation port with DF-1 connector. RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; SVC, DF-1 - SVC defibrillation port with DF-1 connector; RV, IS-1 Bi - Ventricular pacing port with IS-1 bipolar connector; RV, DF-1 - RV defibrillation port with DF-1 connector. RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; SVC, DF-1 - SVC defibrillation port with DF-1 connector; RV, IS-1 Bi - Ventricular pacing port with IS-1 bipolar connector; RV, DF-1 - RV defibrillation port with DF-1 connector; LV, IS4-LLLL - LV pacing port with quadripolar connector (low voltage, low voltage, low voltage, low voltage). Product of USA Product of Malaysia Unique device identification number Medical Device 70 Symbol Description Follow instructions for use on this website Patient identification card label Patient identification Date Healthcare center or physician Physician telephone Lead model/length 71 Symbol Description Storage temperature. Temperature value is indicated adjacent to the symbol. Location of implant 72 73 Abbott Medical 15900 Valley View Court Sylmar, CA 91342 USA

+1 818 362 6822 www.abbott.com

*600312644*

2023-05 ARTEN600312644 02

2999-01-01 PLACEHOLDER

(01)05415067032850(17)990101(21)123456789 2999-01-01 CDHFA300T 123456789 RV, IS-1 Bi LV, IS4-LLLL RA, IS-1 Bi SVC, DF-1 RV, DF-1 1900-01-01 Abbott Medical 15900 Valley View Court Sylmar, CA 91342 USA

+1 818 362 6822 Pat. http://www.abbott.com/patents PLACEHOLDER

(01)05415067032850(17)990101(21)123456789 PLACEHOLDER

(01)05415067032850(17)990101(21)123456789 PLACEHOLDER

(01)05415067032850(17)990101(21)123456789 PLACEHOLDER

(01)05415067032850(17)990101(21)123456789 Only XXXXXXX 2999-01-01 CDHFA300T 123456789 2999-01-01 CDHFA300T 123456789 2999-01-01 CDHFA300T 123456789 2999-01-01 CDHFA300T 123456789 CDHFA300T 123456789 CDHFA300T 123456789 PLACEHOLDER PLACEHOLDER

(01)05415067032850(17)990101(21)123456789

(01)05415067032850(17)990101(21)123456789 CDHFA300T 123456789 CDHFA300T 123456789 CDHFA300T 123456789 CDHFA300T 123456789 CDHFA300T 123456789 1 0

1 0

9 9 9 2 T 0 0 3 A F H D C 9 8 7 6 5 4 3 2 1 1 0

1 0

9 9 9 2 T 0 0 3 A F H D C 9 8 7 6 5 4 3 2 1 1 0

1 0

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PLACEHOLDER

(01)05415067032843(17)990101(21)123456789 2999-01-01 CDDRA300T 123456789 SVC, DF-1 RV, DF-1 RA, IS-1 Bi RV, IS-1 Bi Only 1900-01-01 xxxxxxxx Abbott Medical 15900 Valley View Court Sylmar, CA 91342 USA

+1 818 362 6822

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0 1 C D D R A 3 0 0 T 1 2 3 4 5 6 7 8 9 2999-01-01 123456789 CDDRA300T PLACEHOLDER PN 123456789 PLACEHOLDER XXXXXXXX

To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 07-18-2023 Ref: Attestation Statements Part 2.911(d)(5)(i) and Part 2.91 1(d)(5)(ii) Filing Re. KDB 986446 DO1 FCC ID: RIAICDRFNGQ Dear Sir or Madam, St. Jude Medical Cardiac Rhythm Management Division (CRMD) (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. We also certify that, as of the date of the filing of the application, the applicant is not identified on the Covered Lis as an entity producing covered equipment. If you have any questions, please contact us Yours sincerely, Perry Li 15900 Valley View Court Sylmar, CA 91342, USA T: +1 818 493 3793 Ji@abbott.com St. Jude Medical Cardiac Rhyth Management Division (CRMD) 15900 Valley View Court Syimar, CA 91342 USA Main 818 362 6822 mem ST. JUDE MEDICA

Ic ui To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 07-24-2023 Ref: Attestation Statements Part 2.91 1(d)(7) Filing FCC ID: RIAICDRFNGQ Dear Sir or Madam, St. Jude Medical Cardiac Rhythm Management Division (CRMD) (the applicant) certifies that, as of the date o the filing of the application, St. Jude Medical Cardiac Rhythm Management Division (CRMD) is our designated U.S. agent for service of process for the above referenced FCC ID. St. Jude Medical Cardiac Rhythm Management Division (CRMD) accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. St. Jude Medical Cardiac Rhythm Management Division (CRMD) accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service of process for the above referenced FCC ID. Designated U.S. Agent Information:

Name: St. Jude Medical Cardiac Rhythm Management Division (CRMD) Address: 15900 Valley View Court, Sylmar CA 91342 Contact Person: Perry Li Tel.: 818-493-3793 Email: perry.li@abbott.com FRN: 0028172476 Sincerel t. Jude Medica ardiac Rhythm Managemen Division CRMD U.S. agent company name printed name U.S. agent company name signature St. Jude Medical Cardiac Rhyth Management Division (CRMD) 15900 Valley View Court Sylmar, CA 91342 USA St. Jude Medical Division CRMD Applicant printed na Applicant signature ST. JUDE MEDICA

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Perry Li 15900 Valley View Court tl . Syl gem ST. JUDE MEDICAL CA 91342 ann MORE CONTROL. LESS RISK United States T: +1 818 493 3793 Perry.li@abbott.com May 30, 2023 TUV SUD America Inc. 10 Centennial Drive Peabody, MA 01960, USA Dear Sir or Madam, Pursuant to FCC Rule Part 2.1043, we hereby submit a request for C2PC for FCC ID:

RIAICDRFNGQ Description of the change: Adding new models to the NGQ product family to support new header configuration which allows compatibility with DF-1 cardiac leads with no changes to the circuitry internal to the device can Sincerely,

Ci gem ST. JUDE MEDICAL aan MORE CONTROL. LESS RISK St. Jude Medical Cardiac Rhythm Management Division (CRMD) 15900 Valley View Court Sylmar, CA 91342 USA Main (818) 362-6822 Date (05/26/2023) Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: RIAICDRFNGQ Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission's Rules, St. Jude Medical hereby requests permanent confidential treatment of information accompanying this application as outlined below:

Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation St. Jude Medical also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (can list up to 180) days:

Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: Perry Li, Title: Associate Research Fellow

TUV SUD America Inc. 10 Centennial Drive Peabody, MA 01960, USA Dear Sir or Madam, We, St. Jude Medical 15900 Valley View Court Sylmar, CA 91342, hereby certify the differences betwee the certified models and the new models subject to this certification as detailed in the following tables are valid and true. Yours sincerely, Management Division (CRMD) 15900 Valley View Court Sylmar, CA 91342 USA ST. JUDE MEDICA Name: Perry Title: Associate Research Fello CDVRA300T CDVRAS500T CDVRA6O0T CDVRA700T CDVRA800T

| DF1 VR Header _ New model CDDRA300T CDDRAS500T CDDRA600T CDDRA700T CDDRA800T DF1 DR Header New model CDHFA300T CDHFA500T CDHFA600T CDHFA700T CDOHFA800T DF1 Quad (HF) Header New model Difference Product Models Difference Status CDVRA500Q Product Models CDVRA600Q CDVRA700Q CDVRA800Q VR Header Certified CDDRA300Q CDDRAS00Q Product Models CDDRA600Q CDDRA700Q CDDRA800Q DR Header Certified CDHFA300Q CDHFA500Q CDHFA600Q CDHFA700Q CDHFA800Q CRT-D (HF) Header Certified Note: The grey shaded cells indicate the existing certified model Difference Status