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

Model Number	97810
Medical Device Problem Codes	Failure to Interrogate (1332); Malposition of Device (2616); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider (hcp) and a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that they were trying to put the device into mri mode, but they were getting "device not responding".The caller stated that the patient indicated they hadn't used the implant or external equipment for a long time.The agent walked the caller through repositioning the communicator but they continued to receive "device not responding." the agent walked the caller through using the recharger and they described seeing open loop charging screen with the battery in the red and antenna locate numbers.The caller repositioned the recharger multiple times and the hi ghest value they were able to obtain was 15 and noted recharger was warm.While working with the recharger, the agent heard the patient in the background say "it hurts." the agent asked if the caller could palpate the implant and they were not able to feel it.The agent reviewed that the caller could continue to reposition the recharger to try and get higher numbers to see if they could obtain better connection to which the implant would start charging normally.The issue was not resolved through troubleshooting.The patient was redirected to their hcp to further address the issue.The patient indicated the implanting hcp was no longer practicing and didn't provide a current managing hcp.The agent transferred the caller to national answering service (nas) to page a representative.
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.

• 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: 50937696
• Report Number: 3004209178-2026-16560
• Device Sequence Number: 15886451
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: (01)00763000203849(17)220528
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 05/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 12/09/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female