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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Communication or Transmission Problem (2896)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2pb8x); product type: 0200-lead; implant date (b)(6) 2023.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 Description

Information was received from a friend/family member regarding a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient needs an mri and they are having trouble getting the communicator to locate the device.Caller states they charged it all night and it was green but when they unplugged it, there was no light--agent reviewed this is expected behavior of the communicator; the caller did indicate the bluetooth light flashed when communicator was turned on.The caller was not with the patient/product at the time of the call.The issue was not resolved through troubleshooting.The caller will call in when they are with the pt for assistance. the patient called back with external devices present.Agent reviewed normal device use and patient was able to sync successfully to the ins.Patient added that they have had falls and plan to undergo x-ray to check the lead placement.Patient had increased amplitude up to 5.0 and indicated it was comfortable and did not bother them.Ps reviewed how amplitude impacts ins battery longevity.Patient decided to decrease to a lower amplitude at this time until they can follow up with managing physician. mri technologist called today to discuss mri.A pre-scan was completed and it appears that the lead may not be in the correct location per caller.Caller stated that lead looked to be sitting in the buttock tissue and not near the sacral nerve.Caller stated that patient had multiple falls in (b)(6) 2023.Hcp has ordered x-rays and is evaluating them at this time.Agent reviewed that if lead is not in correct location, would not recommend doing the mri.

• Brand Name: INTERSTIM X
• 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: 19009743
• MDR Text Key: 339061002
• Report Number: 3004209178-2024-08171
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: Other
• Type of Report: Initial
• Report Date: 03/30/2024

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: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 05/03/2022
• 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: 61 YR
• Patient Sex: Male