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

Model Number	97810
Medical Device Problem Codes	Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 urinary/bowel dysfunction.It was reported that they have difficulty finding optimal recharger position in order to connect to ins, and it will frequently start searching/beeping again.Patient confirmed they can palpate the ins and feel it easily.Last time they charged they were able to toggle between good and excellent charge quality by bending forward at the waist and holding the recharger over the ins, however it took about an hour and 30 minutes to go from 30% to 100% and their hand went numb from holding it so long.Reviewed general expectations that charge quality can be effected by implant depth and position.Patient stated they have had been going to physical therapy for unrelated sciatic issues and wondered if this could have moved the ins.Reviewed possible risks and recommendations to not rub or manipulate the device.Patient was driving at the time of the call so no troubleshooting was possible.Patient will call back next week.
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
Additional information was received from the patient (pt).They reported that they advised the patient to call patient services.The patient mentioned that they can get a good connection at times, but the connection only lasts for about a minute before the recharger loses connection altogether and starts beeping/searching again.The recharger belt worked for the patient in the beginning, but they don't use it anymore.The patient has tried moving their body in different positions, (standing, sitting, lying down, leaning forward), but they still struggle to maintain good coupling.The patient stated that leaning forward seems to work the best for them, but they cannot remain in that position for over an hour and their hand will fall asleep.The patient mentioned that the ins battery was dead at the time of the call.During the call the recharger app indicated that the ins was 10% charged and therapy was turned off.The patient was able to maintain a good connection while standing and leaning forward, and the connection was maintained for a few more minutes while seated and leaning forward.However, the recharger would lose the connection after a minute or two and the patient had to keep repositioning the recharger or change the position of their body to get the connection back.The patient mentioned that their husband has tried positioning the recharger over the ins for them, but they got the same result.The patient was redirected to their hcp to further address the issue.
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: 23391503
• Report Number: 3004209178-2025-18229
• Device Sequence Number: 18637833
• Product Code: EZW
• UDI-Device Identifier: 00763000596736
• UDI-Public: (01)00763000596736(17)261114
• 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: 2025
• 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): 11/20/2025

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 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 05/22/2025
• 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: 67 YR
• Patient Sex: Female