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

Model Number	97810
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence, urinary/bowel dysfunction.It was reported that the reason for the call was the caller reported it was taking a long time to charge the implanted neurostimulator.The caller met with the patient in office and confirmed the recharging speed was set to fast, the patient did not notice a large amount of heat, and the recharger connected quickly to the implant and was charging with excellent connection.However, it took 30 minutes to increase from 40% to 50% in office.The caller confirmed they were able to connect with the clinician app without issue, impedances were normal and usage data indicated patient hasn't made any program changes, only increased stim by 0.1 ma in the last month.The caller stated that there was no recharging data available whatsoever.The caller stated patient charged weekly when the implant was about 40% and it took around 2 and a half hours.The caller mentioned having to troubleshooting micro implants in the past.The issue was not resolved through troubleshooting.The agent reviewed it was unclear what the issue was and agreed to replace the recharger.A request was sent to the repair department to replace the recharger.
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 ; 7635265677
• MDR Report Key: 25241978
• Report Number: 3004209178-2026-08702
• Device Sequence Number: 21263655
• Product Code: EZW
• UDI-Device Identifier: 00763000596736
• UDI-Public: (01)00763000596736(17)260614
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2026
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 12/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 46 YR
• Patient Sex: Female