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); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Codes	Incontinence (1928); Urinary Incontinence (4572)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that for the last 2-3 months they experienced a loss of therapeutic benefit.The patient said they were bed wetting and going through at least 3 nighttime pads because they couldn't hold it anymore.The patient mentioned they were taking a medication as well, but that wasn't helping either.A couple of days ago the patient increased the amplitude on program 1 from 1.5 ma to 1.6 ma, but they didn't feel any stimulation.The patient mentioned that they just had hip surgery and were numbed "down there," so they wondered if that was why they couldn't feel stimulation.Agent reviewed stimulation expectations and considerations for therapy optimization.The patient decided to increase the amplitude and confirmed they felt comfortable stimulation.The patient will maintain stimulation level and continue to monitor symptoms.
Additional Manufacturer Narrative
B3.Date is estimated; year is 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: 50558998
• Report Number: 3004209178-2026-14820
• Device Sequence Number: 10507569
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: (01)00763000203849(17)220528
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 12/08/2020
• 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: 65 YR
• Patient Sex: Female