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

Model Number 97800

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Pocket Stimulation (1463)

Patient Problems Diarrhea (1811); Undesired Nerve Stimulation (1980); Sleep Dysfunction (2517); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 04/05/2024

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 disfunction and urge incontinence.It was reported that they were having a lot of diarrhea that seemed to start a week and a half ago when they also started otezla medication for psoriasis.Patient stated they called the doctor's office and asked for a manufacturing representative (rep) to help change the programs.Patient reported they were last put on program 7.Patient service specialist asked and patient stated they had been on quite a few programs in the past.Agent walked patient through how to change programs.During the call, patient mentioned seeing an error message on the handset with no code.This message was resolved with exiting the app and re-entering.Patient increased amplitude and was feeling stim somewhat at the bike seat area and in the buttock.Patient tried program 6 and was feeling stim at communicator site.Patient then tried program 5 and felt comfortable stim at 0.8 ma in the bike seat area.Patient mentioned they had had bladder issues at night for about the last month getting up 3 out of 5 nights with overflow leakage, and that they had a fall 3-4 weeks ago.Agent suggested patient update hcp that prescribes otezla.Patient will maintain stimulation level and will track symptoms in a diary.Redirect to doctor if issue persists.

• 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: 19191680
• MDR Text Key: 341725802
• Report Number: 3004209178-2024-09836
• 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: P080025
• 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: 04/26/2024

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: 04/16/2024
• Initial Date FDA Received: 04/26/2024
• Date Device Manufactured: 02/03/2023
• 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: 86 YR
• Patient Sex: Female