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); Migration or Expulsion of Device (1395)

Patient Problems Incontinence (1928); Urinary Frequency (2275); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 had been having to go to the bathroom 2 -3 times a night.The issue has been going on for at least two months.Possibly could have started in 2023.They had to change their pads.The patient doesn't know why it is doing this.They had always kept the numbers down low.Last week they had to bump it up to 4.6, but never felt it when it was bumping up.As soon as they started walking in the door they had to go.They can't hold it.They are kind of wet on the pads and not a little bit wet but a lot of wet.Patient has had no falls, accidents, or medical procedures.They had to have an mri and they had to turn it completely off.Nothing has changed in diet or anything.Walked caller through checking settings.They were on program 1 at 4.6 ma.On the call the patient increased the stimulation to 5.2 ma.They had mentioned in the past they were at 2.2 something ma.Patient will maintain stimulation level and will continue to track symptoms.Confirmed stimulation was comfortable.Caller also reported they can feel the lead wire more now then in the past.Patient reported blood pressure was 200/110, and had to do chemo.

Manufacturer Narrative

Continuation of d10: product id 978b128, lot# va2lcph, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 20-jan-2024, udi#: (b)(4).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

Additional information was received from the patient.They reported that they are not sure what caused them to not feel stim but it if happens again they will go to another person.It was reported that the issue was resolved.

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va2lcph.Product type lead 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19078175
• MDR Text Key: 339857704
• Report Number: 3004209178-2024-08789
• 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,Followup
• Report Date: 05/14/2024

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 Expiration Date: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 04/28/2022
• 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
• Treatment: "SEE H11...."
• Patient Sex: Female
• Patient Weight: 91 KG