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

Model Number 97800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Incontinence (1928); Itching Sensation (1943); Discomfort (2330); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

Event Date 03/27/2024

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 urge incontinence and urinar y/bowel disfunction.It was reported that they were having a lot of discomfort around the anal area.Patient states they increased the stimulation as they were told to but it was very tense and around the anal area.Patient stated it was a problem to sit sometimes.Patient also mentioned a strange thing that happened about a week ago where it felt like an "electric" went from one hip to the other but then it went away and they didn't pay much attention to it at all.Patient states this issue started about the 27th.Patient states the therapy seemed to work fine until it started leaking.Patient states sometimes it does a great job with their symptoms and sometimes it doesn't.Patient states the doctor never discussed switching programs but they think the started on program 1 and are now to program 3.Agent reviewed how to switch and recommended the patient follow up with their healthcare provider to further address the issue. patient also mentioned that they are experiencing itching where the incision site is located that is telling them that it's healing.Patient states it's itching and tingling which isn't a bad thing.

• 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: 19097523
• MDR Text Key: 340694520
• Report Number: 3004209178-2024-09014
• 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: 04/12/2024

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: 04/08/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 01/08/2024
• 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: 82 YR
• Patient Sex: Female