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

Model Number 97800

Device Problems Unintended Collision (1429); Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 02/15/2024

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 dysfunction and urge incontinence.It was reported that the patient's ins used to help them and stopped helping a couple of month ago, now they do not think it is working, but in the morning they wet on themselves before they get to the bathroom and have to change clothes all over again, they have ended up wearing one adult diaper and two pads.Patient reported they have been on program 1 since implant and they have tried increasing till they felt the tingle and they tried decreasing but it has not helped.Pt said they called their doctor's office and were told they have to call medtronic the manufacturer first.Reviewed interstim therapy optimization information, control equipment general use and function and recommended keeping a symptom diary to track results.Pt chose and was successful to activate a new program and increase confirming comfortable sensation.Offered and sent email with quick guide, symptom diary and in terstim information.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.  pt said they had a fall 3-4 months ago and they are not a small person.

• 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: 19153994
• MDR Text Key: 340728620
• Report Number: 3004209178-2024-09513
• 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: 04/22/2024

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: 04/15/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 12/21/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female