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

Model Number 97800

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Numbness (2415); Paresthesia (4421); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 03/26/2024

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.

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 manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (ins) for urge incontinence and urinary/bowel dysfunction.It was reported that the rep called to report inability to connect to pt's ins.Caller was with pt in exam room.Caller reported they attempted several times toconnect without success.Caller reported trying communicator both under and over the clothes, repositioning the communicator, confirmed blue tooth connection, and confirmed correct app.Agent suggested attempting to connect outside of the exam room and to restart handset and communicator.Both of these were attempted unsuccessfully.Pt reported they had "several falls," but that was 2 months ago.Today 2024-mar-26 was the first day they were unable to connect to the ins.Last successful connection was a week ago.Pt reported having minimal relief of incontinence symptoms the entire time they've had the device.Since implant, pt had been slowly increasing their settings (program 3 for a few weeks, program 4 for a few weeks), skipping programs 5 and 6, until last week when pt reported they "maxed out" the amplitude on program 7.Pt could feel "numbness and tingling" in that area, but continued to have incontinence symptoms.After 2 days, pt remained in program 7, but decreased amplitude to 3.5ma.Caller stated the pt had been at rate of 14 hz and pulse width of 210 micr oseconds.Caller reported last impedance test being day of surgery, which was normal.At that time, pt started describing symptoms and recalled managing healthcare provider (hcp)  reviewing the goal of at least 50% symptom improvement.Caller asked pt if they were having at least 50% symptom improvement, but pt did not give a straight answer and, instead, continued to talk about their urinary incontinence.Agent reviewed battery longevity and factors that play into it.Agent reviewed possibility of replacing implant and returning old one to [manufacturer] for analysis.Agent attempted to assist caller with pulling an event log, but unsuccessful so caller was redirected to healthcare it (hcit).

• 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: 19042099
• MDR Text Key: 339437659
• Report Number: 3004209178-2024-08478
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: 04/04/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/04/2024
• Date Device Manufactured: 06/07/2023
• 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: 85 YR
• Patient Sex: Male