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

Model Number 97810

Device Problems Failure to Interrogate (1332); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy.It was reported that for about a month and a half, they've been having issues with their recharger.The patient stated that it would connect to the handset but it wouldn't connect to charge their implanted neurostimulator.Patient services asked the patient to clarify what the issue was and the patient stated it was just that it wasn't charging their ins and that they'd been struggling and that it was not good so they reached out to their managing health care provider and the healthcare provider then reached out to the manufacturing representative (rep).Patient stated the rep had called them early on but the patient stated they (the patient) "dropped the ball" because they had other health issues going on and they had been in and out of kaiser.Patient stated they've been very frustrated because they couldn't charge because the charger wouldn't connect to the ins.Patient services offered to troubleshoot with the patient but the patient was at work and didn't have their charging equipment with them at the time of the call.Patient services reviewed the patient to call back to troubleshoot once they were with their charging equipment.Patient stated they would call back.Additional information was received from the patient.Patient called back.Patient repeated information previously noted regarding trouble charging ins.Patient was able to connect to ins and see charging screen on handset during the call.Patient said they have to lay flat on the ground to get it to charge and that the ins is deeper this time.Reviewed information regarding recharger and ins placement.Patient was redirected to continue working with hcp.

Manufacturer Narrative

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
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19214241
• MDR Text Key: 341569300
• Report Number: 3004209178-2024-10020
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female