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

Model Number 97800

Device Problems Intermittent Continuity (1121); Unintended Collision (1429)

Patient Problem Urinary Frequency (2275)

Event Date 03/04/2024

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 they noticed they weren't able to hold their bladder as long as they wanted to and that they couldn't feel the vibration anymore.The patient stated they'd gotten used to it and that every once in a while, they would feel it again so it took them a while to get their external equipment out to take a look at their settings.The patient's reason for call was that 2 days ago, they'd fallen through the ceiling and hit the ground on their back 9 feet below that and that they'd broken a rib but they wanted to check to see if they could connect to their settings and there was concern if all was well or not.Patient services walked the patient through connecting to their therapy settings.The therapy was on and the patient was able to increase the stimulation to a comfortable level.The external devices were functioning as intended.Patient denied they felt the stimulation in the bike-seat and stated it was a little to the left of the bike-seat but that wasn't new.Patient stated that's where they always felt the stimulation.Patient services reviewed stimulation and programming considerations with the patient and the patient stated they thought the therapy was working ok now that they'd been able to connect.Patient services redirected the patient to follow up with their health care provider (hcp) to check their implanted system since the fall and the patient stated that they'd moved so they currently did not have a managing health care provider (hcp).Patient services sent the patient physician listings at the patient's request.The patient was going to locate a physician and follow up with that hcp to check the implanted system.Patient stated they would monitor their symptoms in the meantime.

Manufacturer Narrative

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

Additional information was received from the patient.They reported that after a while they get used to the pulse and they don't feel like it is working so they get it set up and increase the number.Patient called into resolve the situation and they set it higher and it works fine and is ok now.It was reported that the issue was resolved.

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.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: 19059109
• MDR Text Key: 340476997
• Report Number: 3004209178-2024-08634
• 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,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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 01/13/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 86 KG