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

Model Number	97810
Medical Device Problem Codes	Electromagnetic Interference (1194); Failure to Deliver Energy (1211); No Device Output (1435)
Health Effect - Clinical Code	Urinary Frequency / Polyuria (2275)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction, urinary urgency.It was reported that the reason for the call was that the patient reported a therapy issue.The patient mentioned they had been going to the bathroom more frequently and urinating more often.The patient stated they went to a berry farm and had to turn off the therapy when passing through a metal detector; however, they were not able to turn the therapy back on afterward.The agent instructed the patient to connect to the ins.The patient was able to connect to the ins and turn the therapy back on.However, when the therapy was turned back on, the patient experienced sudden and extreme pain.The agent instructed the patient to decrease the stimulation, and the patient confirmed they felt comfortable after the adjustment.The patient was redirected to their healthcare provider if symptoms persist.

• 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: 25660480
• Report Number: 3004209178-2026-10914
• Device Sequence Number: 10379621
• Product Code: EZW
• UDI-Device Identifier: 00763000596736
• UDI-Public: (01)00763000596736(17)260128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 01/28/2026
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 08/01/2024
• 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: 54 YR
• Patient Sex: Female