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

Model Number	97810
Medical Device Problem Codes	Charging Problem (2892); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy.It was reported that they are having trouble charging the recharger.All three lights are blinking green.It was noted in the repair request that there was scrolling lights on the recharger.The issue started this week.Walked caller through resetting the recharging device.The troubleshooting steps that were taken on the call did not resolve the issue.Agent asked if they store the recharger in the dock when not using it.They said they try to.Sent request to repair to replace the wireless recharger.
Additional Manufacturer Narrative
Continuation of d10: product id wr9220 lot # serial # (b)(6); implanted: explanted: 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), ubd; udi#: h3: analysis of the returned wireless recharger (s/n: (b)(6) revealed that the patient's complaint was confirmed.The device led's scroll continuously and the device is unresponsive.The flash read/write protection bits have become set.No visual anomalies were observed.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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50579111
• Report Number: 3004209178-2026-14897
• Device Sequence Number: 10195969
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: (01)00763000203849(17)211014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• 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: 78 YR
• Patient Sex: Female