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

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and urge incontinence.It was reported that they had a change in some of the messages they get on the controller when they go in to turn the therapy on or off.The patient stated the messages didn't make sense to them.The patient stated that since maybe a couple months ago, when they went into the screen to connect to their therapy settings they would instantly get an error that said "maximum settings.The system is operating at maximum settings.The therapy cannot be increased," even though they did not increase the stimulation.It would just happen as soon as they connected to their settings.The patient stated they would then turn the therapy off and when they went to turn the therapy back on again they would get the same message.Patient stated the reason why they'd been turning the therapy off was because they were doing transcutaneous electrical nerve stimulation and they never had the therapy on when they did it.Patient stated that they had never put the unit over the ins implanted components and explained they had been using transcutaneous electrical nerve stimulation because they were having trouble with their gi.Patient services reviewed the meaning of the me ssage with the patient and redirected the patient to follow up with their health care provider (hcp) about the issue to check the implanted system.The patient denied having had any falls or traumas that led to the situation.They stated they had a lead wire migrate 2 cm and it had to be reprogrammed but that was all they could think of.Patient further clarified that the lead migrated in may of 2023 after they used a particular cushion.They stated it was something with the way that sat that impacted the tines.Patient stated they had to wait a while to be reprogrammed but that it was done in july 2023.Patient services asked the patient if they'd experienced the message on any other setting and the patient stated they didn't want to play around with anything because it was working at that setting for them and they'd been on that setting for a long time.Patient also stated they were at work thinking about cyber security and inquired about the risk for the ins being hacked.Patient services reviewed information with the patient.The patient stated they would periodically put the handset on wi-fi to check for any software updates because they knew those were pushed on occasion and that they'd noticed some improvement to the "software" in the past after one update but that's all they used the wi-fi for.The caller stated they'd been on the same program and setting for a long time and that the therapy was still helping their symptoms.Patient services again redirected the patient to their managing health care provider to further address the issue.Patient stated they would reach out to their hcp to check the implanted system.

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id (b)(4) (lot: va2j2z3); product type: 0200-lead; implant date (b)(6) 2022; explant date 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: 19202823
• MDR Text Key: 341290890
• Report Number: 3004209178-2024-09935
• 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: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2024
• Date Device Manufactured: 09/27/2021
• 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
• Treatment: SEE H11...
• Patient Sex: Female