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

Model Number 97800

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Communication or Transmission Problem (2896)

Patient Problems Incontinence (1928); Pain (1994); Urinary Frequency (2275)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator for urinary/bowel dysfunction and urge incontinence.It was reported that the patient did good with the therapy for the first month to month and a half but then it stopped helping their symptoms and they were back to going to the bathroom frequently and having to change pads again.The patient stated their back also started hurting and their stomach hurt, and their doctor thought they had a urinary tract infection so the patient was tested but it came back negative.The patient also mentioned how they initially had trouble turning the black handset on but that they were able to "mash the buttons" on the back and get it to power on.The patient stated they would sometimes see a "yellow" 'device not responding' message as well.Patient services offered to assist the patient in connecting to their settings to see if the patient could resolve the 'device not responding screen' and the patient was able to successfully connect to their settings.The external devices were functioning as intended.The therapy was on but the patient stated they didn't feel "anything" at all, st imulation-wise.Patient services reviewed therapy expectations as well as programming and stimulation considerations with the patient and the patient stated sometimes they would feel the stimulation in their leg but they usually felt the stimulation in their vaginal area but they were feeling nothing now.The patient wanted to increase the stimulation.At first when they started to increase the stimulation they said they were moving the communicator all around to get a "better connection" and patient services reviewed with the patient to keep the communicator in place over the ins site and against the skin and they wouldn't get the "yellow" 'device not responding' screen.The patient was able to increase the stimulation to a level where the patient could feel the stimulation comfortably in their bike-seat region.The patient was going to monitor their symptoms now that a change had been made and stated they would follow up with their managing health care provider (hcp) at their follow-up appointment on (b)(6)2024 documented reported event.No further action was taken by patient services.Caller called back and reported that they are going to the bathroom too much and if they drink something, it's not long before they have to go to the bathroom.The caller reported that they have to get up at night to change pads.The caller also reported that it hurts when they sit down sometimes on their "whole rear end" and that sometimes it hurts and sometimes it doesn't.Agent asked the caller if the therapy is helping their symptoms, the caller reported sometimes it does and sometimes it doesn't.Advised the caller to connect with the implant and the patient reported feeling a tingle in the hip when it was trying to connect.Upon connection it was determined that the therapy was turned off.The caller did not know why it was off.Helped caller change programs and increase the stimulation.The caller reported that it started to hurt their stomach.Agent reviewed that the stimulation should not be in the stomach.Advised caller to change programs.Caller changed programs and saw the screen that the therapy was off.Reviewed with the caller that stim was off and asked if the stomach pain was subsiding and they thought it was.During the call, the caller experienced numerous issues with "no device found" and had to reposition the communicator and retry.Because of this, agent explained the fear that the patient would adjust the stim, and it would become uncomfortable and then they would be unable to turn it back off due to the communication issues.Advised the caller to leave stim off and to follow up with the hcp as the stimulation should not be felt in the stomach.The caller also experienced issues with the touchscreen responding throughout the call and they reported that their hands do not have circulation and are cold.Agent suggested trying to warm them up to get the touchscreen to respond consistently.The caller also reviewed that they are having surgery on the 17th to have a stent placed, due to bad leg veins.

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 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: 19142029
• MDR Text Key: 340567704
• Report Number: 3004209178-2024-09381
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 07/13/2023
• 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: 75 YR
• Patient Sex: Female