FCC ID: LF597800 Ultra Low Power Active Medical Implant (ULP-AMI)

97800 Communications Regulation Reference Sheet Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Asia-Pacific Medtronic International Ltd. 50 Pasir Panjang Road

#04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510 Medtronic, Inc. 2021 All Rights Reserved M018238C001 Rev A

*M018238C001*

2021-11-01 Communications Regulations The following is a list of communications regulations that apply to the Model 97800. 175 kHz H 30 dBA/m 10 . United States Compliance FCC ID: LF597800 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. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. Canada Compliance IC: 3408D-97800 This device contains licence-

exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-

exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference.

(2) This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans leprsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

1) Lappareil ne doit pas produire de brouillage;2) Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Australia and New Zealand Compliance European Union Compliance Conformit Europenne

(European Conformity) English Hereby, Medtronic declares that this Radio Equipment Model number 97800 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:

www.MedtronicCompliance.eu This product operates at 175 kHz with an H-field strength of less than 30 dBA/m at 10 m.

(Bulgarian) Medtronic

, 97800 2014/53/.

www.MedtronicCompliance.eu etina (Czech) Spolenost Medtronic tmto prohlauje, e toto radiov zazen, slo modelu 97800, odpovd poadavkm smrnice 2014/53/EU. pln text EU Prohlen o shod je k dispozici na nsledujc internetov adrese:

www.MedtronicCompliance.eu Tento vrobek pouv frekvenci 175kHz, piem intenzita pole H je ni ne 30 dBA/m ve vzdlenosti 10m. dansk (Danish) Medtronic erklrer hermed, at dette radioudstyr modelnummer 97800 er i overensstemmelse med direktiv 2014/53/EU. Den fulde tekst i EU-

overensstemmelseser-

klringen kan lses her:

www.MedtronicCompliance.eu Dette produkt fungerer ved 175 kHz med en H-feltstyrke p mindre end 30 dBA/m ved 10 m. Deutsch (German) Hiermit erklrt Medtronic, dass dieses Funkgertmodell Nr. 97800 der Richtlinie 2014/53/EU entspricht. Der vollstndige Text der EU-

Konformittserklrung steht unter der folgenden Internetadresse zur Verfgung:

www.MedtronicCompliance.eu Dieses Produkt arbeitet mit 175 kHz und einer H-Feldstrke von weniger als 30 dBA/m in einer Entfernung von 10 m. eesti (Estonian) Kesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga 97800 on vastavuses direktiiviga 2014/53/EL. Kogu EL-i vastavusdeklaratsiooni tekst on saadaval jrgmisel internetiaadressil:

www.MedtronicCompliance.eu See toode ttab sagedusel 175 kHz H-vlja tugevusega vhem kui 30 dBA/m 10 m juures.

(Greek)

, Medtronic M 97800 O 2014/53/E.

www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 m. espaol (Spanish) Por la presente, Medtronic declara que este equipo de radio, modelo nmero 97800 cumple la Directiva 2014/53/EU. El texto completo de la Declaracin de Conformidad CE est disponible en la siguiente direccin de internet:

www.MedtronicCompliance.eu Este producto opera a 175 kHz con una intensidad de campo H de menos de 30 dBA/m a 10 m. franais (French) Par la prsente, Medtronic dclare que cet quipement radio Modle 97800 est conforme la directive 2014/53/UE. Le texte intgral de la dclaration de conformit de l'UE est disponible sur le site Internet:

www.MedtronicCompliance.eu Ce produit fonctionne 175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m. hrvatski (Croatian) Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model 97800 u skladu s Direktivom 2014/53/EU. Cjelokupan tekst europske izjave o sukladnosti dostupan je na sljedeoj internetskoj stranici:

www.MedtronicCompliance.eu Ovaj proizvod radi pri frekvenciji od 175 kHz sa snagom H polja manjom od 30 dBA/m pri 10 m. magyar (Hungarian) A Medtronic ezton nyilatkozza, hogy ez az 97800 tpusszm rdiberendezs megfelel a 2014/53/EU irnyelvnek. Az EU megfelelsgi nyilatkozat teljes szvege elrhet a kvetkez internetes cmen:

www.MedtronicCompliance.eu Ez a termk 175 kHz-en gy mkdik, hogy mgneses trerssge 10 m tvolsgban kevesebb, mint 30 dBA/m. italiano (Italian) Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello 97800 conforme alla direttiva 2014/53/UE. Il testo completo della dichiarazione UE di conformit disponibile su Internet al seguente indirizzo:

www.MedtronicCompliance.eu Questo prodotto funziona a 175 kHz con intensit di campo H inferiore a 30 dBA/m a 10 m. lietuvi (Lithuanian) iuo Medtronic deklaruoja, kad is radijo rangos modelis, kurio numeris 97800, atitinka Direktyv 2014/53/EB. Vis ES atitikties deklaracijos tekst galite rasti iuo interneto adresu:

www.MedtronicCompliance.eu is gaminys veikia 175 kHz daniu, kai H lauko stiprumas yra maesnis nei 30 dBA/m 10 m atstumu. latvieu (Latvian) Ar o uzmums Medtronic apliecina, ka radioiekrta, modea numurs 97800, atbilst Direktvas 2014/53/EK prasbm. Pilnu ES atbilstbas deklarcijas tekstu var skatt vietn www.MedtronicCompliance.eu is izstrdjums darbojas ar 175 kHz frekvenci, un 10 metru attlum t magntisk lauka stiprums ir mazks par 30 dBA/m. Malti (Maltese) Hawnhekk, Medtronic tiddikjara li dan it-Tagmir tar-Radju bin-

numru tal-mudell 97800 huwa konformi mad-Direttiva 2014/53/UE. It-test si tad-

dikjarazzjoni ta konformit tal-

UE hu disponibbli fdan l-

indirizz fuq l-Internet:

www.MedtronicCompliance.eu Dan il-prodott jopera f175 kHz bqawwa H-field ta inqas minn 30 dBA/m f'distanza ta' 10 m. Nederlands (Dutch) Hierbij verklaart Medtronic dat deze radioapparatuur modelnummer 97800 in overeenstemming is met Richtlijn 2014/53/EU. De volledige tekst van de Europese conformiteitsverklaring is te vinden op de website:

www.MedtronicCompliance.eu Dit product werkt op 175 kHz met een H-veldsterkte van minder dan 30 dBA/m bij 10 m. polski (Polish) Firma Medtronic deklaruje niniejszym, e to urzdzenie radiowe, model numer 97800, spenia wymogi okrelone w Dyrektywie 2014/53/UE. Peny tekst deklaracji zgodnoci UE jest dostpny pod nastpujcym adresem internetowym:

www.MedtronicCompliance.eu Ten produkt dziaa na czstotliwoci 175 kHz z nateniem pola H mniejszym ni 30 dBA/m w odlegoci 10 m. portugus (Portuguese) Por este meio, a Medtronic declara que este modelo de equipamento de rdio, nmero 97800, est em conformidade com a Diretiva 2014/53/UE. O texto completo da declarao de conformidade da UE est disponvel no seguinte endereo da Internet:

www.MedtronicCompliance.eu Este produto opera a 175 kHz com uma fora do campo H inferior a 30 dBA/m a 10 m. romn (Romanian) Prin prezenta, Medtronic declar c acest echipament radio numr model 97800 este n conformitate cu Directiva 2014/53/UE. Textul complet al declaraiei de conformitate UE poate fi gsit la urmtoarea adres de internet:

www.MedtronicCompliance.eu Acest produs funcioneaz la 175 kHz cu o putere a cmpului H de mai puin de 30 dBA/m la 10 m. slovenina (Slovak) Spolonos Medtronic tmto vyhlasuje, e toto rdiov zariadenie, model 97800, je v slade so smernicou 2014/53/E. pln znenie vyhlsenia o zhode so smernicami E je k dispozcii na strnke:

www.MedtronicCompliance.eu Toto zariadenie pracuje pri frekvencii 175 kHz s intenzitou poa H niou ako 30 dBA/m na vzdialenos 10 m. slovenina (Slovenian) Druba Medtronic izjavlja, da je ta radijska oprema, tevilka modela 97800, v skladu z Direktivo 2014/53/EU. Celotno besedilo izjave EU o skladnosti je na voljo na naslednjem spletnem naslovu:

www.MedtronicCompliance.eu Ta izdelek deluje pri 175 kHz z jakostjo magnetnega polja H manj kot 30 dBA/m pri 10 m. suomi (Finnish) Medtronic vakuuttaa tten, ett tm radiolaite, mallinumero 97800, vastaa direktiivi 2014/53/EU. EU-

vaatimustenmukaisuus-

vakuutuksen koko teksti on saatavissa seuraavasta Internet-osoitteesta:

www.MedtronicCompliance.eu Tm tuote toimii 175 kHz:n taajuudella, ja sen H-kentn voimakkuus on alle 30 dBA/m 10 m:n etisyydell. svenska (Swedish) Hrmed intygar Medtronic att denna radioutrustning med modellnummer 97800 verensstmmer med direktiv 2014/53/EU. Den fullstndiga texten med intyg om verensstmmelse fr EU finns p fljande internetadress:

www.MedtronicCompliance.eu Den hr produkten fungerar p 175 kHz med en H-fltstyrka p mindre n 30 dBA/m p 10 m.

M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 A52300 PATIENT THERAPY APP FOR SACRAL NEUROMODULATION THERAPY Patient User Guide for InterStim systems with Model 97800 InterStim X neurostimulator Application version 1.0 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Medtronic and the Medtronic logo are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

The BLUETOOTH word and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Medtronic, is under license. The handset, as configured, does not support voice communication and therefore cannot be used to make any calls (including emergency calls). M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 SYMBOLS Explanation of symbols Manufacturer Authorized representative in the European community Importer For USA audiences only Magnetic Resonance (MR) Conditional Magnetic Resonance (MR) Unsafe M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TABLE OF CONTENTS HOW TO USE THIS GUIDE ............................ 6 Contact Information ......................................... 7 How to Contact Medtronic ............................... 8 Important Tips ................................................... 8 GLOSSARY ................................................... 10 GENERAL WARNINGS & PRECAUTIONS .. 14 Warnings ......................................................... 14 Precautions ..................................................... 14 ABOUT THE PATIENT THERAPY APP ......... 16 Intended Use ................................................... 16 How Does the App Work? .............................. 16 How do I use the patient therapy app on the handset? ..............................................................18 Accessing the Patient Therapy App ............. 18 Patient Therapy App Tutorial ......................... 19 Home Screen................................................... 19 Accessing system information ......................... 20 USING THE PATIENT THERAPY APP .......... 22 Main Features ................................................. 22 Using the Communicator to Connect your Handset and Neurostimulator ....................... 22 Adjusting Therapy Amplitude ....................... 25 Turning Therapy On or Off ............................. 25 Switching Programs ....................................... 26 4 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Checking Battery Level .................................. 27 Table 1. Neurostimulator battery level descriptions .........................................................28 MRI EXAMINATIONS .................................... 29 Preparing for Your MRI Appointment .......... 29 Activating MRI Mode Using Your Handset ... 31 Table 2. MRI mode eligibility displays ............... 33 Turning Therapy On After Your Scan ............ 34 Visiting Your Clinician to Activate MRI Mode 34 ADDITIONAL INFORMATION ....................... 36 Data Security and Network Connectivity ..... 36 Software Updates ........................................... 37 Safety and Technical Checks ........................ 37 Cleaning and Care .......................................... 37 Disposal........................................................... 38 TROUBLESHOOTING .................................. 39 Therapy (stimulation) Problems .................... 39 Table 3. Possible scenarios and solutions for therapy problems ................................................39 App Notifications ............................................ 48 Table 4. Important app notifications .................. 49 Other Troubleshooting Scenarios ................. 52 Table 5. Other troubleshooting scenarios and solutions .............................................................53 2021-11-01 English A52300 5 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 HOW TO USE THIS GUIDE Welcome to your guide to the patient therapy app for Medtronic Bladder or Bowel Control Therapy delivered by the InterStim system

(also called sacral neuromodulation therapy). We created this guide to help you understand how the patient therapy application (app) on your handset works. Please read the entire guide before using the app to adjust your therapy. Ask your clinician to explain anything that is unclear. Information about how to contact Medtronic is on page 8 and the back cover. A glossary is provided in this guide to describe terms relating to your therapy that may be unfamiliar to you. Terms that are bold throughout this guide are defined in the glossary. Glossary terms and definitions begin on page 10. Important safety information regarding your therapy begins on page 14. The USING THE PATIENT THERAPY APP section provides instructions on how to use the app to adjust your therapy after your InterStim device has been implanted. This section of the guide includes information on turning your therapy on and off, adjusting your therapy settings, checking battery level, and changing programs (if applicable). See page 22. 6 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 HO W TO USE T HIS GUID E The MRI EXAMINATIONS section includes instructions for using the app to prepare for an MRI scan. See page 29. The TROUBLESHOOTING section provides explanations and solutions for various troubleshooting scenarios you may encounter while using your handset. This includes explanations on important patient therapy app notifications, and who to contact if your handset is lost or broken. TROUBLESHOOTING starts on page 39. Contact Information Be sure to write down important contact information in the following fields, so its easy to find in the future:

Clinician Name Clinician Telephone Number _________________ _________________ Hospital Name Hospital Telephone Number _________________ _________________ 2021-11-01 English A52300 7 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 H OW TO USE THIS GUIDE How to Contact Medtronic Medtronic is available to answer any technical or troubleshooting device related questions or concerns you may have about your InterStim system components. Have the name and telephone number of your clinician at hand if you have any questions or problems. See the Medtronic contacts on the back cover of this manual. For assistance in the US, call 1-800-510-

6735. Support is available Monday through Friday from 8:00AM to 5:00PM (central time). If you lose your identification card, contact:

USA Medtronic Inc., Patient Registration Services Mail Stop SLK35 800 53rd Avenue NE Minneapolis, MN 55421-1200

(1-800-551-5544) Europe, Africa, Middle East, and Asia-

Pacific Countries Refer to the Medtronic contacts on the back cover of this manual. Important Tips The following includes some things to keep in mind while using sacral neuromodulation therapy:

8 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 HO W TO USE T HIS GUID E Always carry your handset and communicator. The patient therapy app on the handset is the only way to adjust or turn therapy on and off. Also, it is very important that you bring your handset and communicator to all follow-

up appointments, including appointments with other clinicians. During certain procedures, you may need to turn your therapy off. Bring this guide to all your appointments and share this information with clinicians, dentists, MRI operators, and other professionals who may not be familiar with the InterStim system patient therapy app. When necessary, you should also bring your Patient Therapy Guide for InterStim systems; it contains important information about sacral neuromodulation therapy that your clinicians should be aware of. Refer to GENERAL WARNINGS &

PRECAUTIONS on page 14 and throughout the manual for information on what you should and should not do while using the InterStim system. Notes:

For more information about the communicator, see the TM90 Communicator Instructions for Use. 2021-11-01 English A52300 9 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 GL OSSARY GLOSSARY The following is a list of glossary terms that may be unfamiliar to you. The words that appear in bold in this guide are defined here for your convenience. Caution Clinician Communicator A statement that describes an action or situation which could harm the patient or damage the device. The term clinician is used in this guide to refer to a specialized medical professional such as a doctor, nurse, medical technician, or specialist. A communication device that includes a radio-

frequency technology that allows the neurostimulator and the handset to communicate with each other. 10 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Electromagnetic interference Handset G LO SSARY A strong field of energy near electrical or magnetic devices that could prevent the neurostimulator from functioning properly, damage the neurostimulator, or even injure you. A hand-held electronic device used by the patient to control therapy settings and to turn the neurostimulator on and off. InterStim system An implanted system Lead that sends mild electrical pulses to sacral nerves in order to treat your symptoms. A thin wire with protective coating that has metal electrodes on one end and a connector on the other. Patient therapy app An app used to modify sacral neuromodulation therapy. 2021-11-01 English A52300 11 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 GL OSSARY Neurostimulator The power source of a Pair (concerning a device or devices) neurostimulation system. It contains the battery and electronics that control the stimulation. The process of wirelessly connecting in order to send and receive information between the patient therapy app, the communicator, and the implanted neurostimulator. Precaution See Caution. Program Sacral nerves Stimulation A specific combination of stimulation settings assigned to deliver therapy to a specific site. Nerves located near the base of the tailbone just above the cleft of the buttocks. Sacral nerves control the bladder, bowel, and pelvic organs. The delivery of electrical pulses to a specific site. 12 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Therapy Therapy amplitude G LO SSARY Treatment of a disease or condition. When neuromodulation therapy is prescribed, a neurostimulation system is used to deliver therapy

(stimulation) to a specific site. The strength or intensity of stimulation measured in milliamps. Therapy settings Refers to the features that define the therapy. The clinician programs all therapy settings. You can adjust some of your therapy settings within clinician-defined limits. A statement that describes an action or situation which could seriously harm the patient. Warning 2021-11-01 English A52300 13 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 GENER AL WARNINGS & PRECAUT IONS GENERAL WARNINGS &

PRECAUTIONS Warnings WARNING: Wound contact Do not use the communicator on an unhealed wound. The communicator is not sterile and contact with the wound may cause an infection. Keep a sterile bandage or barrier between the wound and the device. Precautions CAUTION: Communication interference from EMI sources When using your handset and communicator to communicate with your neurostimulator, move away from equipment that may generate electromagnetic interference (EMI) or turn off the likely source of EMI. EMI may disrupt communication between the handset, communicator, and neurostimulator. Examples of EMI sources are computer monitors, and motorized wheelchairs. For more information about EMI, refer to the Patient Therapy Guide for InterStim systems. CAUTION: Contact your clinician if you experience unintended changes in therapy. Other warnings and precautions are found throughout the manual. For warnings, precautions, and adverse events related to sacral neuromodulation 14 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 GENERAL WARNI NG S & PREC AU T ION S therapy, refer to the Patient Therapy Guide for InterStim systems. If you did not receive the Patient Therapy Guide, contact your clinician. 2021-11-01 English A52300 15 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT THERAPY A PP ABOUT THE PATIENT THERAPY APP The patient therapy app is a software application (app) for Medtronic Bladder or Bowel Control Therapy delivered by the InterStim system with the Model 97800 InterStim X neurostimulator. The app is intended to be used for controlling and monitoring your therapy. It is installed on and used with the handset to adjust your therapy. Intended Use The patient therapy application provides the user interface for patients to adjust therapy and obtain system information from an implantable neurostimulator as part of a neurostimulation system for sacral neuromodulation therapy. How Does the App Work?

Your clinician used the clinician app on your handset to program your therapy settings. Your therapy is provided through the implanted neurostimulator (INS). Your clinician uses programs to control the delivery of your therapy. If needed, your clinician will use the clinician app to change your therapy settings. You will use the patient therapy app to:

Turn your therapy on and off, page 25 Adjust therapy amplitude within the limits set by your clinician, page 25 16 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT T HER APY A PP Change programs (if available), page 26 Activate MRI mode, page 31 The patient therapy app on the handset uses a communicator to communicate wirelessly with the implanted neurostimulator (INS) by sending signals to and receiving signals from the neurostimulator. To send and receive the signals, the communicator must be connected or paired to the handset as well as the neurostimulator. Your neurostimulator only accepts programming from the clinician app or the patient therapy app. Other devices are not able to program your neurostimulator. Your clinician will initially set up the handset according to your specific needs, after the implant procedure. However, if for any reason the communicator and/or handset has been disconnected or unpaired from the neurostimulator, or you received a replacement device(s), you will need to reconnect. For more information about connecting the communicator to the handset and implanted device, see TROUBLESHOOTING on page 39. Note: Make sure to keep your handset and communicator charged and with you at all times, in the event that you need to adjust or turn your therapy off. 2021-11-01 English A52300 17 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT THERAPY A PP How do I use the patient therapy app on the handset?

Use the patient therapy app on the handset to adjust your therapy as directed by your clinician. The handset has a touchscreen display that allows you to tap or select icons that are displayed on the screen. Use one finger when tapping icons. You can use the touchscreen in the following ways depending on the function or task:

Short, light taps for icon selection Swipe left/right to turn your therapy on or off. Note: None of the physical buttons on the handset itself will alter your therapy. Instructions for using the app to adjust your therapy settings begin on page 25. Accessing the Patient Therapy App You can access your patient therapy app

(Figure 1) by locating the appropriate icon on the main screen of the handset. Tap the icon to open the app and begin using it. The first time you or your clinician opens the app, it will request permission for data storage. Tap OK to continue. Then tap ALLOW for the next messages. 18 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT T HER APY A PP InterStim X My Therapy Figure 1. InterStim X My Therapy app icon Patient Therapy App Tutorial The app includes a brief tutorial that will help you understand its basic functions. When you open the app for the first time you will be presented with this tutorial. If you would like to view the tutorial again in the future, you can do so at any time. To view the tutorial:

to open the menu, and select Tutorial Tap from the list of options. Home Screen The Home screen is the screen where you will adjust your therapy settings. Figure 2 provides an overview of the Home screen.

Note: The Home screen may look slightly different from the image shown depending on how your clinician set up the handset. 2021-11-01 English A52300 19 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT THERAPY A PP Tap to access menu options. Tap the arrows to increase or decrease therapy amplitude. Tap the PROGRAM button to switch between programs (if available). Slide the arrow to turn therapy on or off. Figure 2. Home screen Accessing system information Use the patient therapy app to access neurostimulator system information as well as 20 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ABOUT THE PATIENT T HER APY A PP check the battery level of the neurostimulator, and prepare for MRI. (Figure 3). Figure 3. Accessing system information To view system information:

in the corner of the screen and select Tap from the following:

About to see general information about your system Battery for battery level (See Checking Battery Level on page 27 for details.) MRI to prepare for MRI (See MRI EXAMINATIONS on page 29 for important information.) Tutorial to review basic functions 2021-11-01 English A52300 21 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 U SIN G THE PATIENT THERAPY A PP USING THE PATIENT THERAPY APP Your clinician will provide complete guidelines about when you may want to adjust your therapy. The following sections provide instructions for using the app to modify your therapy. Main Features The patient therapy app has a few basic features that allow you to manage certain aspects of your therapy. Using the app, you can perform the following tasks:

Adjust therapy amplitude (stimulation), page 25 Turn your therapy On or Off, page 25 Switch between programs (if available), page 26 Access the app tutorial, page 19 Access system status and neurostimulator battery level information, page 27 Activate MRI mode, page 31 Using the Communicator to Connect your Handset and Neurostimulator The patient therapy app will need to communicate with your implanted neurostimulator. Use the following procedure to use the communicator to connect your 22 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 USI NG THE PATI ENT THERAPY APP handset and implanted neurostimulator before adjusting your therapy. To connect your handset and neurostimulator using the communicator:

1. Press on the communicator to turn the communicator on. The communicator will attempt to connect to the handset

(Figure 4). The blue LED indicator on the communicator will continuously blink to indicate it is on and in discovery mode.

Note: For details about button and functions of the communicator, see the TM90 Communicator Instructions for Use. Figure 4. Connection screen 2021-11-01 English A52300 23 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 U SIN G THE PATIENT THERAPY A PP 2. Open the patient therapy app on the handset. 3. Once the communicator has successfully connected to the handset, the blue LED indicator on the communicator will be solid and no longer blinking. Place the communicator over the neurostimulator site (Figure 5), and tap FIND DEVICE on the handset.

Note: If the communicator fails to connect to the neurostimulator, readjust the location of the communicator over the neurostimulator and tap RETRY. Figure 5. Connecting the communicator to the implanted neurostimulator 24 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 USI NG THE PATI ENT THERAPY APP 4. Once the communicator has successfully connected to the implanted neurostimulator, you will see the tutorial

(if enabled) or the Home screen where you can adjust your therapy as directed by your clinician. Adjusting Therapy Amplitude The patient therapy app allows you to adjust your therapy amplitude to your comfort level as your needs change. To adjust your therapy amplitude:

1. Place the communicator over the neurostimulator site. 2. On the Home screen, tap the arrows to increase or decrease therapy amplitude as directed by your clinician. Turning Therapy On or Off In the patient therapy app you have the ability to turn therapy on or off. To turn therapy on:

1. Place the communicator over the neurostimulator site. 2. On the Home screen, swipe the On/Off switch from Off to On.

Note: You can also turn therapy on by on the Home screen. tapping 2021-11-01 English A52300 25 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 U SIN G THE PATIENT THERAPY A PP To turn therapy off:

1. Place the communicator over the neurostimulator site. 2. On the Home screen, swipe the On/Off switch from On to Off. 3. A pop-up will appear confirming that therapy has been turned off. Tap OK to acknowledge therapy has been turned off.

Note: You can also turn therapy off by on the Home screen until the tapping therapy amplitude is set to -- (off). Switching Programs Programs are created by your clinician to provide you with the best therapy results. Each program has different therapy settings. If multiple programs are made available to you, you have the ability to switch between the available programs as directed by your clinician. Note: If your clinician set up your handset so that only one program is available to you, switching programs is not an option. To switch between programs:

1. Place the communicator over the neurostimulator site. 2. Tap the PROGRAM button at the bottom of the Home screen. 3. Select the desired program from the list, and tap DONE. 26 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 USI NG THE PATI ENT THERAPY APP 4. Tap the arrows to adjust the therapy amplitude to the desired setting. See Adjusting Therapy Amplitude on page 25 for more information. Checking Battery Level To check neurostimulator battery level:

Tap select Battery. in the corner of the Home screen and Figure 6. Battery screen 2021-11-01 English A52300 27 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 U SIN G THE PATIENT THERAPY A PP Table 1. Neurostimulator battery level descriptions My Battery Neurostimulator battery level OK LOW Consult your clinician if a low battery icon appears, or if you receive a low battery message. Notes:

For information about communicator battery level and charging your communicator, see the TM90 Communicator Instructions for Use. For information about handset battery level and charging the handset, follow the directions provided with your handset. 28 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 MRI EXAMIN AT ION S MRI EXAMINATIONS Magnetic Resonance (MR) Conditional:

Depending on what kind of neurostimulation system components that you have implanted, you may be eligible for one of the following types of magnetic resonance imaging (MRI) scans:

MRI scans of the head only (this is referred to as head-scan only eligible). MRI scans of any part of your body (this is referred to as full-body scan eligible).

Note: Always consult the clinician managing your InterStim system before having an MRI scan. Magnetic Resonance (MR) Unsafe:

External devices such as your handset or communicator are unsafe in the MR environment. Do not take any external devices into the MRI scanner (magnet) room. Preparing for Your MRI Appointment WARNING: Do not undergo an MRI scan without first determining if you are eligible and consulting with your clinician. Inform the MRI clinician that you have an implanted device, and activate MRI mode before your MRI scan, while you are still outside the scanner

(magnet)room. Failure to do so may result in serious or permanent harm to you or damage to your implanted system. CAUTION: Deactivate MRI mode when the MRI scan is complete and you are outside 2021-11-01 English A52300 29 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 M RI EXAMINATIONS the MRI scanner (magnet) room. Failure to deactivate MRI mode and return therapy amplitude to the previous level may result in a return of symptoms. Before Your MRI Scan:

1. Consult the clinician managing your InterStim system before having an MRI scan. 2. Bring your handset, communicator, and Medtronic patient ID card to every MRI appointment, and inform the MRI clinician that you have an implanted device. 3. If the clinician managing your InterStim system gave you an MRI scan eligibility sheet, bring it to the MRI appointment along with your handset and communicator. 4. Activate MRI mode before your MRI scan, while you are still outside the scanner

(magnet) room, using the following instructions. MRI mode turns therapy off and prepares your InterStim system for scanning. Notes:

Inform the MRI clinician if you think you have a fever. Having a fever may affect your ability to have an MRI scan. Remember to charge the handset and communicator prior to the MRI appointment. To obtain the MRI guidelines, the MRI clinician can refer to the contact information on the 30 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 MRI EXAMIN AT ION S back cover of this manual, or the MRI clinician can go to www.medtronic.com/mri. Activating MRI Mode Using Your Handset The handset must be used to place the InterStim system in MRI mode before an MRI scan. Ensure you are outside of the MRI scanner (magnet) room before proceeding with the following steps. When you use the handset to place your InterStim system in MRI mode, scan eligibility icons will appear on the screen (See Table 2. MRI mode eligibility displays on page 33). Show that screen to the MRI clinician.

Note: During the MRI scan, leave the handset outside the scanner (magnet) room with the InterStim system in MRI mode. Do not tap DEACTIVATE. Therapy must remain off. 1. Press on the communicator to turn the communicator on. The communicator will attempt to connect to your handset, but cannot do so until the patient therapy app is launched. The blue LED light on the communicator will continuously blink to indicate it is on and in discovery mode. 2. Open the patient therapy app on the handset to initiate the connection process. 3. Once the communicator has successfully connected to the handset, the blue LED light on the communicator will 2021-11-01 English A52300 31 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 M RI EXAMINATIONS be solid and no longer blinking. Place the communicator over the implanted neurostimulator and tap FIND DEVICE on the handset.

Note: If the communicator fails to connect to the neurostimulator, readjust the location of the communicator over the neurostimulator, and tap RETRY on the handset. 4. Once the communicator has successfully connected to the implanted neurostimulator, you will be taken to the Home screen. 5. Tap in the corner of the Home screen and select MRI. 6. Tap ACTIVATE to activate MRI mode. 7. One of the following messages will appear:

MR Conditional Full Body Scan Eligible MR Conditional Head Scan Eligible with Transmit/Receive Head Coil MRI eligibility cannot be determined Note: If the handset screen says MRI eligibility cannot be determined, further assessment by the clinician who manages your InterStim system is necessary before scanning. Contact your clinician. 8. After activating MRI mode, show your handset to the MRI clinician with the screen displayed. Do not tap DEACTIVATE or turn therapy back ON until your MRI scan is complete and you are outside the scanner (magnet) 32 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 MRI EXAMIN AT ION S room. See Table 2. MRI mode eligibility displays for descriptions. Table 2. MRI mode eligibility displays Screen image, text and description MR Conditional Full Body Scan Eligible MR Conditional Head Scan Eligible with Transmit/

Receive Head Coil MRI eligibility cannot be determined

Notes:

Your scan eligibility depends on several factors. Show your handset to the MRI clinician with the screen displayed. If the handset screen says MRI eligibility cannot be determined or any other unexpected message, do not proceed with an MRI scan. Contact the clinician who manages your InterStim system.

Do not take your handset, communicator, or any other patient control device into the MRI scanner (magnet) room. 2021-11-01 English A52300 33 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 M RI EXAMINATIONS

Do not deactivate MRI mode until after the MRI scan is complete and you are outside the scanner (magnet) room. Turning Therapy On After Your Scan Deactivate MRI mode when the MRI scan is complete and you are outside the MRI scanner (magnet) room. You can deactivate MRI mode and turn therapy on using your handset, or you can return to the clinician managing your neurostimulation system to have therapy turned back on for you. Complete the following steps to turn therapy on using your handset. 1. Connect to your neurostimulator as usual. 2. On the Home screen, tap then select MRI. 3. Tap DEACTIVATE at the bottom of the screen. 4. Tap DEACTIVATE a second time when prompted. 5. Tap YES when prompted to return to previous therapy settings, if desired.

Note: Contact your clinician if you are unable to turn therapy on. Visiting Your Clinician to Activate MRI Mode Inform the clinician managing your InterStim system that an MRI examination has been 34 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 MRI EXAMIN AT ION S prescribed for you and that you need MRI mode activated. Remember to bring your handset and communicator to every appointment, including the MRI appointment. Your clinician may place your system in MRI mode for you. Keep your neurostimulation system in MRI mode during the MRI scan. The clinician may also give you an MRI scan eligibility sheet to bring to your MRI appointment. Give the MRI scan eligibility sheet to the MRI clinician. 2021-11-01 English A52300 35 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ADD ITI ONAL INFORMATION ADDITIONAL INFORMATION The following sections provide additional information about your device, including information on data security and network connectivity, cleaning and care, and disposal information. Data Security and Network Connectivity The patient therapy app uses and stores data about your health and medical device. This information is protected by the app and handset. Personal files or data you choose to store or access elsewhere on the handset are not protected. You are ultimately responsible for protecting the data that is stored on the handset. To help protect your data, Medtronic recommends the following:

Secure your handset by disabling the Wi-Fi network connection when using the app. Use a trusted, secure Wi-Fi network when Internet access is needed.

Note: Connecting to a Wi-Fi network is not required to use your therapy, however network connectivity is needed for Medtronic app updates and communicator firmware updates. If your handset is lost or stolen, contact Medtronic right away using the contact information at the end of this guide. 36 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ADDITIO NAL INFO RM AT ION If you no longer need the handset to manage your therapy, see Disposal on page 38. If you suspect the security of your handset has been compromised, stop using the app (if possible) and contact Medtronic to document and respond to the suspected incident. Software Updates You might be notified that you should update your software. Connect to Wi-Fi to receive the update. When the update is complete, you can turn Wi-Fi off again. Safety and Technical Checks Periodic safety and technical checks or periodic maintenance of the handset are not required. If the handset requires repair or is nonfunctional, contact Medtronic. Refer to the contact information at the end of this guide. Cleaning and Care Follow these guidelines to ensure that the handset and accessories function properly:

Keep the handset and communicator out of the reach of children and pets. Use the handset and communicator only as explained to you by your clinician or as discussed in this manual and others provided to you by Medtronic. Follow all warnings and cautions in this guide, and the Patient Therapy Guide 2021-11-01 English A52300 37 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 ADD ITI ONAL INFORMATION for InterStim systems provided by your clinician. Handle the handset and communicator with care. Do not drop, strike, or step on the device. Do not dismantle or tamper with the handset or communicator. Do not attempt to service them yourself. Clean the outside of the handset and communicator with a damp cloth when necessary. The handset and communicator are not waterproof. Do not allow moisture to get inside. Disposal Contact Medtronic if you no longer need your handset. Medtronic can help you delete your personal and health data, and dispose of the handset. Contact information for Medtronic can be found at the end of this manual. 38 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TRO UBLESH OOT ING TROUBLESHOOTING The following sections contain information you may use to troubleshoot the patient therapy app, and answers to potential questions you might have while using it. Therapy (stimulation) Problems Table 3 provides troubleshooting scenarios you may encounter, as well as explanations and solutions to resolve problems if you are experiencing issues with your therapy. Table 3. Possible scenarios and solutions for therapy problems Scenario Delayed therapy changes Explanations and/or Solutions You do not feel therapy right away after turning on the neurostimulator or you feel therapy after turning off the neurostimulator. Your clinician may have enabled SoftStart/

Stop so that therapy starts and stops gradually. If SoftStart/

Stop is enabled, it may take a few seconds for your neurostimulator to turn on and off. You may feel a residual effect after the neurostimulator is turned off. 2021-11-01 English A52300 39 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario Intermittent therapy Explanations and/or Solutions You feel your therapy only some of the time. Therapy area changes Not receiving symptom relief Your clinician may have programmed your neurostimulator to turn on and off at regular intervals. If therapy is uncomfortable or symptoms return, call your clinician. You notice an unexpected change in where you feel the therapy (stimulation). Call your clinician. Therapy may be turned off, or the therapy (stimulation) might not be strong enough. 1. Check that your therapy is on, then increase the therapy amplitude as directed by your clinician. 2. If these steps do not solve the problem, call your clinician. 40 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Scenario Uncomfortable or intolerable therapy

(stimulation) Uncomfortable tapping sensation TRO UBLESH OOT ING Explanations and/or Solutions You are experiencing side effects from the therapy

(stimulation). 1. Turn the therapy

(stimulation) down or off. See Adjusting Therapy Amplitude on page 25 or Turning Therapy On or Off on page 25 for instructions. 2. If you are still experiencing uncomfortable therapy

(stimulation), call your clinician. You feel a tapping sensation that is too slow or too fast. 1. Turn the therapy

(stimulation) down or off. See Adjusting Therapy Amplitude on page 25 or Turning Therapy On or Off on page 25 for instructions. 2. If you are still experiencing an uncomfortable tapping sensation, call your clinician. 2021-11-01 English A52300 41 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario Therapy does not relieve your symptoms You have unexpected changes in therapy The handset, or the patient therapy app is unresponsive Explanations and/or Solutions 1. Adjust therapy amplitude OR switch programs (if available). 2. If the issue persists, call your clinician. 1. Turn your therapy off. 2. Turn your therapy on by pushing the up arrow once and slowly increasing therapy amplitude to the desired level OR switch programs

(if available). 3. If the issue persists, call your clinician. Therapy may have stopped:

1. Turn off the power on the handset, then turn the power back on and reopen the patient therapy app. 2. If the issue persists, call your clinician. 42 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TRO UBLESH OOT ING Scenario You will be passing through a theft detector or security device Explanations and/or Solutions Before engaging in any of these activities, see the Patient Therapy Guide for InterStim systems for details. You will be using potentially dangerous equipment You will be having a medical or dental procedure You received external defibrillation The handset is unable to connect to the communicator M017457C001 Rev A 2021-11-01 Turn the therapy off and call your clinician. 1. The communicator is not powered on. You will need to turn on the communicator to communicate with your implanted neurostimulator. Once the communicator is powered on, follow the connection steps

(A) provided at the end of this section to reconnect your existing communicator. 2021-11-01 English A52300 43 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario Explanations and/or Solutions 2. The communicator is not charged or is in the process of charging. You will need to charge the communicator using the charger provided in your product package. Once charged, follow the connection steps

(A) provided at the end of this section to reconnect your existing communicator.

Note: The communicator cannot be used while charging. 3. The communicator is out of range. Make sure the communicator is near the handset. Once in range, follow the connection steps

(A) provided at the end of this section to reconnect to your existing communicator. 44 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TRO UBLESH OOT ING Scenario Explanations and/or Solutions 4. You received a replacement communicator. You will need to connect the new communicator to the handset and the implanted device. Follow the connection steps (B) provided at the end of this section to connect to a new/replacement communicator device. 5. Your communicator needs to be updated. Follow the connection steps (C) provided at the end of this section to update your communicator. 6. If the issue persists, call your clinician. 2021-11-01 English A52300 45 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario Explanations and/or Solutions A. To reconnect with your neurostimulator using an existing communicator you have used before:

1. Make sure the communicator is turned on.

Note: For details about button and functions of the communicator, see the TM90 Communicator Instructions For Use. 2. Open the patient therapy app on the handset. 3. When the communicator has successfully connected to the handset, place the communicator over the neurostimulator site, and tap FIND DEVICE on the handset. Once connected, you will be taken to the Home screen where you can adjust your therapy. 4. If the communicator you would like to connect to is not shown, tap RETRY. 5. If you are having trouble, call your clinician. 46 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TRO UBLESH OOT ING Scenario Explanations and/or Solutions B. To connect using a new or replacement communicator for the first time:

1. Make sure the communicator is turned on.

Note: For details about button and functions of the communicator, see the TM90 Communicator Instructions For Use. 2. Open the patient therapy app on the handset. 3. After the app searches for and fails to find a communicator that has been paired previously, a screen will be displayed showing that the communicator is not found. Tap SWITCH COMMUNICATOR on the handset to connect. 4. Select the communicator serial number found on the back of the communicator that you would like to pair to and tap CONTINUE. The serial number of the communicator should match the serial number shown on the screen.

Note: If the communicator you would like to connect to is not shown, tap RETRY. 5. If you are having trouble, call your clinician. 2021-11-01 English A52300 47 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario Explanations and/or Solutions C. To update your communicator:

1. Connect the handset to a Wi-Fi network. 2. Make sure the communicator is turned on. 3. Open the patient therapy app on the handset. 4. A screen will be displayed showing that an update is needed for the communicator. Tap UPDATE on the handset to update.

Note: The update will take a few minutes to complete. 5. If you are having trouble, contact your clinician. App Notifications Notifications can pop up on the handset while using the patient therapy app to notify you of problems or issues with the InterStim system. Table 4 provides important notifications along with explanations and solutions. 48 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:52 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Table 4. Important app notifications TRO UBLESH OOT ING Explanations and/or Solutions 1. Ensure the Bluetooth on the handset is turned on. 2. Make sure the communicator is fully charged. 3. Reposition the communicator over the neurostimulator, and tap RETRY on the handset. 4. If the issue persists, call your clinician. 1. Reposition the communicator over the neurostimulator, and tap RETRY. Call your clinician. App notification Communicator connection lost Device not responding Internal device data lost or Data lost Implanted neurostimulator

(INS) low battery Your neurostimulator will need to be replaced soon Call your clinician. 2021-11-01 English A52300 49 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING App notification Maximum Settings Reached Note: In addition to the notification, an orange icon will appear. Neurostimulator End of Service System Error Explanations and/or Solutions Your neurostimulator has reached the limit of its therapy (stimulation) range. 1. Turn therapy amplitude down. 2. Swipe the On/Off switch to Off, then to On. 3. Slowly increase therapy amplitude. 4. If the notification is shown again, switch programs (if available) and adjust amplitude to the settings specified by your clinician. 5. If the issue persists, call your clinician. Your neurostimulator battery is depleted. Therapy can no longer be provided. Call your clinician to discuss replacement options. The system has encountered an unexpected error. Call your clinician. 50 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 App notification Device Communication Lost Not Installed Properly Communicator Low Battery No Implant Date Update required TRO UBLESH OOT ING Explanations and/or Solutions Communication is lost or has been interrupted. 1. Close the app and try to reconnect. 2. If the issue persists, call your clinician. The patient therapy app was not installed properly Contact Medtronic support. The communicator battery is low, and may be unable to communicate with the handset and/or the neurostimulator soon. Charge the communicator.

Note: If the communicator battery level is below 10%, the battery will need to be charged to above 10% before use. Implant date not recorded in handset. Call your clinician. Device must be updated to continue. Call your clinician. 2021-11-01 English A52300 51 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING App notification Power on Reset detected Explanations and/or Solutions POR has occurred. 1. Check neurostimulator battery level 2. From the Home screen, swipe the On/Off switch from Off to On. 3. If the issue persists, call your clinician. Other Troubleshooting Scenarios Table 5 provides additional troubleshooting scenarios and solutions. 52 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TRO UBLESH OOT ING Table 5. Other troubleshooting scenarios and solutions Scenario The handset has no power or has lost power The handset will not charge Explanations and/or Solutions 1. The handset battery is depleted. Recharge the handset using the charger. 2. The handset cannot be charged with the charger, or the handset may be damaged or malfunctioning. Contact Medtronic support. 1. The charger is disconnected from the handset. Connect the charger to the handset. 2. The charging cable or wall plug are not fully inserted. Ensure the charging cable and wall plug are fully inserted. 2021-11-01 English A52300 53 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 TR OUBLESHOOTING Scenario The handset is lost or broken Explanations and/or Solutions 3. An incompatible charger is connected to the handset. Connect an appropriate charger to the handset. 4. The charger is defective. Call your clinician. 5. The handset is damaged or malfunctioning. Contact Medtronic support. Contact Medtronic to order a replacement. Medtronic can also attempt to remotely delete your personal and health data from a missing handset. Contact information for Medtronic can be found on the back cover of this manual. You should also call your clinician to say that you have ordered a replacement. 54 A52300 English 2021-11-01 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 2021-11-01 English A52300 55 M017457C001 Rev A 2021-11-01 M017457C_a_001 June 4, 2021 11:53 AM 4.6 x 7.6 inches (116.84mm x 193.04mm) Medtronic Confidential Patient_Programmer_(Tall)_Template.Indd Template version 1: 07_25_2017 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Asia-Pacific Medtronic International Ltd. 50 Pasir Panjang Road

#04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510

*M017457C001*

Medtronic 2021 All Rights Reserved M017457C001 Rev A 2021-11-01 M017457C001 Rev A 2021-11-01

MEDTRONIC CONFIDENTIAL THIS DOCUMENT IS THE PROPERTY OF MEDTRONIC, INC., AND MUST BE ACCOUNTED FOR. INFORMATION HEREON IS CONFIDENTIAL. DO NOT REPRODUCE IT, REVEAL IT TO UNAUTHORIZED PERSONS, OR SEND IT OUTSIDE MEDTRONIC WITHOUT PROPER AUTHORIZATION. REV A Initial release REVISIONS DESCRIPTION AUTHOR DATE SPEC NUMBER REV SHEET 10 May 2021A1 of 5Luke MunroeB05631 1. This specification is a representation of the final Label Design Output generated from a combination of label parts within the associated PDM BOM. Space 2. These label images are the combinations of the Transform template file, LDS (Label Model Data) record, sample trigger data and representative views of the label die lines. Space 3. The Serial Number, Use-By Date, Lot Number, Date Of Manufacture, PIN Number, GTIN, GTIN Version (if used), Product Number (REF) and Barcodes are shown for example only. These fields are variable and are to be supplied by Manufacturing at the time of printing. Not all fields will be used for all labels. Space 4. The Label Set is to be printed using a 600 DPI LaserJet printer or equivalent. The individual labels and PIC are to be printed using a 300 DPI Zebra thermal transfer printer. Space 5. The Trigger Data shown on the Label Set Image might differ from the printed label. Space 6. Spacing and text wrapping shown in the image may differ slightly from actual printed label. Content of printed version is accurate. Space 7. The label printed in Manufacturing must be at an equal or later Model Data and Template revision as shown on the image. Space 8. This specification is controlled by Neuromodulation Package Engineering. Space 9. This specification has been assessed for key design characteristics which are defined as

- Critical KCC - Identified characteristic is classified as Critical and impacts safety.

- Major KCM - Identified characteristic is classified as Major and impacts safety and/or performance. MEDTRONIC, MINNEAPOLIS,MINNESOTAUSA MEDTRONICCONFIDENTIAL Thisdocumentisthepropertyof Medtronic,andmustbe accountedfor.Information hereonisconfidential.Donot reproduceit,revealitto unauthorizedpersonsorsendit outsideMedtronicwithout properauthorization. TITLE LABEL IMAGE SPECIFICATION NEURO 97800 CE MARK IMAGE SPEC TEMPLATE: A86694_c DATE 10-May-2021 SCALE N/A MODEL 97800 Size B ENGINEERING Luke Munroe SPECNUMBER B05631 REV SHEET A 2 of 5 MEDTRONICCONFIDENTIALThisinformationisconfidential.Donotreproduceit,revealit tononMedtronicpersonsorsenditoutsideMedtronicwithoutproperauthorization. LASER NOTE: IMAGES NOT TO SCALE SPEC NUMBER REV SHEET B05631 A 3 of 5 Shelf Box Label Sterile Pack Label FYR Labels End Label 1 End Label 2 MEDTRONICCONFIDENTIALThisinformationisconfidential.Donotreproduceit,revealit tononMedtronicpersonsorsenditoutsideMedtronicwithoutproperauthorization. ZEBRA NOTE: IMAGES NOT TO SCALE SPEC NUMBER REV SHEET B05631 A 4 of 5 PIC MEDTRONICCONFIDENTIALThisinformationisconfidential.Donotreproduceit,revealit tononMedtronicpersonsorsenditoutsideMedtronicwithoutproperauthorization. NOTE: IMAGES NOT TO SCALE SPEC NUMBER REV SHEET B05631 A 5 of 5

September 6, 2022 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Request For Long Term Confidentiality FCC ID No.: LF597800 Model: 97800 Good day:

Medtronic, Inc. (Medtronic) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Section 0.459 of the Commissions Rules, 47 C.F.R. 0.459 (2001) and 726920 D01 Confidentiality Request Procedures v01r02, following grant of the application. The requested materials for confidential treatment as set forth in these exhibits are segregated into long term and short-term confidential exhibits of the application are those for which confidentiality is sought. Model 97800 is implanted in a human body therefore not accessible and not retail to the general public as they follow FDA regulation to be sold under prescription and/or health care specialist specific licenses. The Model 97800 is also inaccessible to the radio parts as the entire circuit including the antenna is inside the human body and then encapsulated in a welded titanium enclosure and under specific vacuum and gas filler and parts epoxy in the can. Short term confidentiality for a period of 180 days is requested for the following exhibits:

None.

(1) identification of the specific information for which long term confidential treatment is sought:

Schematics Block Diagram Operational Description Internal Photos

(2) identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission:

The proceeding is that involving the application for equipment authorization (certification) under FCC ID No.: LF597800

(3) explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged:

This information is embodied in circuit diagrams, detailed explanations, a block diagram of a device designed for implantation in patients and/or use by authorized medical professionals that are contractually precluded from disclosing such information from third parties. As such, this Request For Long Term Confidentiality FCC ID No.: LF597800 Model: 97800 Page 2 material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques.

(4) explanation of the degree to which the information concerns a service that is subject to competition:

The information for which confidentiality is sought is employed in the design and manufacture of medical devices that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers.

(5) explanation of how disclosure of the information could result in substantial competitive harm:

Disclosure would, in effect, give away the fruits of the labors of Medtronics engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic.

(6) identification of any measures taken by the submitting party to prevent unauthorized disclosure:

The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. This device is not retail to public and is implanted in the body by trained physician

(FCC KDB 726920 II.3. a) & c)). Model 97800 is implanted in a human body therefore not accessible and not retail to the general public as they follow FDA regulation to be sold under prescription and/or health care specialist specific licenses. The Model 97800 is also inaccessible to the radio parts as the entire circuit including the antenna is inside the human body and then encapsulated in a welded titanium enclosure and under specific vacuum and gas filler and parts epoxy in the can.

(7) identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties:

To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought.

(8) justification of the period during which the submitting party asserts that material should not be available for public disclosure:

This material should not be disclosed for at least ten years. While improvements in design are likely to be made during this period, disclosure of the design information would lead to insights into both designs and manufacturing techniques and could have an adverse competitive effect for many years to come. This application contains information that will be used in future applications for similar devices. Moreover, the communications aspects of this device are employed in the programming of medical implant devices and in the transmission of highly private medical information. Disclosure of the information for which confidentiality is sought could jeopardize the protection of such personal private medical information generated for the benefit of patients into whom a device has been implanted. As such, it is important that Request For Long Term Confidentiality FCC ID No.: LF597800 Model: 97800 Page 3 information pertains to the design and operation of this device not be made available to unauthorized persons who might attempt to use knowledge of the design to compromise the applications for which the equipment will be employed. Request For Long Term Confidentiality FCC ID No.: LF597800 Model: 97800 Page 4

(9) any other information that the party seeking confidential treatment believes may be useful in assessing whether its request for confidentiality should be granted:

See item 8 above. Note that the equipment for which approval is being sought will be employed in applications that inherently carry a premium on security. Respectfully, Guillaume Girard SR RF Regulatory Manager Technical Fellow Medtronic, Inc. Tel 763-526-0652 g.guillaume@medtronic.com

775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: certification@bureauveritas.com Website: https://www.cps.bureauveritas.com/

Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Revised wording (obsolete) Updated company template (obsolete) Updated letter information (obsolete) Added FCC ID field (obsolete) Updated company name & logo (current) Updated References and Contact info Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 6.0 To 1.0 2.0 3.0 4.0 5.0 6.0 7.0 Approved Date Nov-14-2006 Sept25-2007 Jan-31-2012 May-23-2014 Sep-16-2014 Jun-27-2018 Aug-30-202 02/17/2022 To: BVCPS, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Project and Product Certification Representative Authorization Letter We, Medtronic, Inc. hereby authorize Bureau Veritas Consumer Product Services, Inc. to act as a Certification Body for certifying for the following project(s):

FCC ID: LF597800 Product Description: Ultra Low Power Active Medical Implant (ULP-AMI) Model: 97800 We affirm that between Bureau Veritas Consumer Product Services, Inc. and Medtronic, Inc., any difference in understanding, including test plan, measurement methods, applicable standards and relevant procedures and processes have been resolved prior to commencement of testing activities. Sincerely, Girard Guillaume Senior Compliance manager g.guillaume@medtronic.com 7000 Old Central Ave NE RCW 235 MINNEAPOLIS Minnesota United States 55432 SCS-F018: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 7.0