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

Model Number	97810
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Data Problem (3196)
Health Effect - Clinical Codes	Incontinence (1928); Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the reason for the call was patient reported therapy issue.The patient stated that they had a fall in the driveway after receiving the implant in 2020, and the ins had been working well until this year.The patient mentioned that the communicator battery would drop over 2 to 3 hours.The patient confirmed that they charged the ins to 100% a day before.The patient confirmed that they had not consulted their hcp and stated they were making adjustments themselves with the help of their daughter, who is a nurse.The agent sent a replacement request to repair for the communicator and transferred the call to hcit to address the handset issue.The patient was redirected to their healthcare provider to further address the issue. upon further review, the patient mentioned that they do not know if the ins was getting weak, gradually going down, or shutting off and causing them to urinate all over themselves.The patient stated that when they connected to the ins, they saw that they were in program 6 at 0.6 ma, and it jumped down to 0.5 ma without them pressing the down button.The patient described it as "like it has a mind of its own." the patient also confirmed that they plug in the communicator after using it instead of turning it off because they do not want the communicator to die on them, so they keep it charged all the time.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed 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.

• 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: 50535903
• Report Number: 3004209178-2026-14737
• Device Sequence Number: 12252957
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: (01)00763000203849(17)211214
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 12/14/2021
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 06/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 71 YR
• Patient Sex: Female