MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	97810
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id tm90p01 serial# (b)(6) product type accessory product id wr9220 serial# (b)(6) product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: wr9220, serial/lot #: (b)(6).H3: analysis of the wireless recharger (s/n: (b)(6)) revealed that no anomalies were visually observed.Led¿s scroll continuously.Device is unresponsive.Flash sector read/write protection bits have become set.B3: date is estimated; month and year are valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a patient regarding an external device it was reported that unresponsive recharger.Caller stated that their wireless recharger wont power on nor take a charge stating that they "batter in the recharger is dead.".They said this started happening 2 months ago, sometime in june.Patient says that the green light is on the dock when it's connected to the charging cord.They inspected the dock and recharger and said there is no visible damage to the metal contacts.Patient said they store their charger in a drawer for less than a week at a time so it doesn't sit depleted without charge for extended periods of time.The issue was not resolved.A request was sent to repair to replace the recharger.Additional information was received from the patient.They reported that they received the replacement wireless recharger and they thought they charged their internal implant to full because they heard the recharger sound a tone.The patient said the reason for the call was that the communicator wouldn't connect with the therapy app.During the call, the patient was instructed how to use the communicator.The patient saw "device not responding".The patient was then instructed to start a charging session.The patient was able to start implant charging session and the implant showed charging at excellent.The patient was instructed to hold the recharger over the implant for 30 minutes, and the screen then eventually transitioned to the red charging battery and showed 10% charged, therapy off.The patient was advised to charge the implant to above 30% so the implant would have enough charge for the communicator to connect with the implant.The patient said they might call back for assistance once the implant was charged.The patient's device record showed the implant location as being on the left, but the patient said their implant was on the right side.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23487053
• Report Number: 3004209178-2025-18941
• Device Sequence Number: 9490870
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: (01)00763000203849(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0293-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 62 YR
• Patient Sex: Female