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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Communication or Transmission Problem (2896)

Patient Problems Undesired Nerve Stimulation (1980); Swelling/ Edema (4577)

Event Date 03/28/2024

Event Type  malfunction  

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.

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and urge incontinence.It was reported that they were told to set up the patient's ins the day after implant so they were attempting to use the external devices to connect to the patient's settings and "activate the therapy" and they had a hard time connecting to the ins.Patient services confirmed the caller was doing what needed to be done to connect but the caller stated it kept circling and communicating with the ins but then go to device not responding.Caller stated it had been really difficult but confirmed the patient had some really thick bandages over the ins site that they were going over with the communicator and also the patient has been swollen at the incision site since yesterday.The caller stated that the patient had "a lot going on back there" right now.Patient services reviewed with the caller that the communicator was not a sterile piece of equipment and also reviewed that the swelling and the bandages could be having an impact on the intermittent communication with the ins site and that they should wait until the patient's swelling went down and the patient started healing more and the bandages were removed before trying to connect.The caller stated they were finally able to connect to the patient's therapy settings and turn the therapy on however they did periodically lose connection (even though they hadn't moved the communicator) and had to try a few times to connect again.The caller stated when they did successfully turn the therapy on, the patient was not feeling the stimulation in their "pelvic region" like they felt during the trial, but rather the patient was feeling it "where the tailbone would be to the right hand side- 3-4 inches, in that square right where the ins was and down the patient's right leg.Patient services reviewed stimulation considerations with the caller and patient.Caller stated the patient no longer felt the stimulation now and patient services reviewed device description/function and programming considerations and suggested working with the caller to help them find a program setting where the patient could feel the stimulation in the bike-seat region.Patient services worked with the caller to connect to the patient's settings.It took a bit for the communicator to pair to the handset and when it did pair, when they went to connect they would get 'communicating with device' for 6-8 seconds and it would go to device not responding again.Patient services suggested the caller and patient move to another room in case of potential emi and when they did, they were successfully able to connect to see the patient's settings.The patient was on program 1 at.9 ma.Patient services was going to walk the patient through switching to a new program and then the caller got device not responding again.The caller stated again that they hadn't moved the communicator.Caller was able to connect again and switched to program 2 however the patient still felt the stimulation at the ins site.Caller then went to program 3 and was able to increase the stimulation to where the patient felt the stimulation comfortably in their bike-seat region.Caller stated "it's working now." patient services redirected the caller to follow up with the patient's health care provider (hcp) about patient feeling the stimulation at the ins site on programs 1 and 2 and to monitor the patient's symptoms now that a change had been made.Caller stated the patient had a follow up appointment in 2 weeks but they were going to monitor the patient's symptoms and healing and reach out to the hcp about symptom concerns, where the patient was feeling the stimulation and any concerns about the patient's healing.Caller stated they'd call patient services back if they still had issues with communicating with ins after patient was more healed.

• 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: 19020302
• MDR Text Key: 339216956
• Report Number: 3004209178-2024-08280
• 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: 04/02/2024

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: 03/29/2024
• Initial Date FDA Received: 04/02/2024
• Date Device Manufactured: 12/08/2023
• 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: 62 YR
• Patient Sex: Female