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

Model Number	3058
Medical Device Problem Codes	Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	04/01/2026
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 urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that they had gone several times in the last maybe month or 6 weeks and stated they adjusted therapy but reported they still were having a great deal of leakage and stated it didn't seem like it had taken care of it completely.Patient stated it didn't seem like they were where they used to be (patient did not clarify this).Agent walked patient through steps to connect with their implant to adjust therapy settings.Patient stated their healthcare provider did not give direction on what therapy adjustments to make but directed patient to contacted patient services to make adjustments.Agent reviewed role of patient services.Agent walked patient through steps to connect with their implant.Patient confirmed therapy was on.Agent reviewed therapy considerations.Patient increased stimulation to a comfortable level.Patient will monitor symptoms.Agent redirected patient to their managing healthcare provider if issue persists.When asked for event date, patient stated they had op en heart surgery on april 1st and stated everything got "changed" they guess so they noticed leakage since then and thought it would get better but it had not gotten better, so patient stated it had been going on for several months.
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: 50551634
• Report Number: 3004209178-2026-14808
• Device Sequence Number: 21398946
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: (01)00763000449711(17)230128
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 08/10/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 07/30/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Female