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); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Discomfort (2330)

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed 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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient reported that their daughter had been in the hospital and the patient stated they sat with their daughter for 9 hours a day for 8 days.The patient stated they were able to do a little bit of walking but they hadn't been moving around as much and that their right hip had started to really bother them.Patient stated they didn't think it had been because of the implant but they felt a knot and it was really sore and their daughter told them "mom, that's your implant" though they felt like it was still pretty much in the same place as it had been, they didn't know if they 'dislodged it,' but it maybe felt a little closer to the surface now.The patient stated the therapy was still working as well as it had before and they waited to see if the pain/knot would get better but it's been about a week now and it's not better.Patient services reviewed activities and the impact they could have on the implanted system like repetitive movements and the patient stated they did sit differently at the hospital, that their hip pushed up on it the way they were sitting at the hospital which was different from how they usually sat in their office.Patient services redirected the patient to follow up with their managing health care provider (hcp) to check the implanted system.The patient stated they were going to see their hcp tomorrow (2024-apr-19) so they would talk to the hcp about their concerns then.Documented reported event.No further action was taken by patient services.The patient stated they went in for their first follow up checkup back in june 2023 and that the next time they went in for their second checkup the hcp told them they could change the setting to see if it would help them better which the patient hadn't been aware that they could do and then the hcp did make a change to the patient's settings which seemed to help the patient more after that though they weren't satisfied still and they had gone to that 2nd check up to discuss getting bulkamed which they said you could liken to botox but it was something they put in the urethra to help with their leaks as an additional treatment to try as the interstim therapy hadn't been giving them enough relief.Patient stated they would be going tomorrow (2024-apr-19) to see their hcp for the bulkamed procedure.Patient stated when they were first implanted they weren't taught anything and that they were given 6 manuals but they didn't know which ones applied.Patient services reviewed with the patient to call back at a later time when it was convenient for them to review the external devices and therapy considerations and device description/function as well as discuss the patient therapy manuals.Patient stated they may call back to discuss the therapy and the manuals at a later date.

• 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: 19202173
• MDR Text Key: 341279044
• Report Number: 3004209178-2024-09921
• 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: 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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2024
• Date Device Manufactured: 04/11/2023
• 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: 80 YR
• Patient Sex: Female