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

Model Number	3058
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor, urinary dysfunction/sacral nerve stim.It was reported that the reason for the call was the caller said the patient was in the hospital and needed an mri of their brain.The caller said they wouldn't do the mri because they said the internal battery was low.The caller stated they tested the device at the hospital when the patient was in their room and they could pull up the program on the handset.The caller was not with the patient at the time of the call, so troubleshooting could not be performed.The caller mentioned that the device didn't work enough and didn't help the patient enough that they wanted to do the surgery again to replace the stimulator.The caller was going to call back when with patient to see if they can put the device in mri mode.The caller called back with the external devices.Patient services reviewed external device use and the caller was able to connect to the ins successfully and activate mri mode.Additional information was received from a friend/family member and the patient.The patient representative called back reporting they went in for an mri today and when they opened the therapy application they encountered a message that said "internal device data lost." the agent reviewed possible end of service (eos) and redirected to the managing physician.The agent reviewed mri eligibility considerations with regard to eos and redirected to the managing physician.When the patient was asked to clarify the statement "the device was not working," the patient reported their symptom control was not effective.Steps taken to resolve the issue were they would most likely have it removed.Device removal or replacement was not yet planned.The patient also reported the hospital would not perform an mri due to low battery internal.

• 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: 25283545
• Report Number: 3004209178-2026-08930
• Device Sequence Number: 10059735
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: (01)00763000449711(17)230128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 01/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 07/28/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female