MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211)

Patient Problem Urinary Frequency (2275)

Event Date 02/20/2022

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that last night the patient got a message on the handset that said "turned off for security purposes". the pt said, they had a miserable night.Patient services asked why and the pt said, they had return of symptoms.The device wasn't working and patient was getting up every 25 minutes(also stated every 15-30 minutes) to go to the bathroom.They stated that when they tried to adjust settings it said 'blocked for security'.Patient services reviewed that the clinician app requires a password.Patient services walked the caller through the steps of going into the micro my therapy application and placing the communicator over the stimulator.Patient was able to connect without issues and adjust to where they could feel stim.The troubleshooting steps that were taken on the call resolved the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13668536
• MDR Text Key: 289767388
• Report Number: 2182207-2022-00372
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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
• Report Date: 03/04/2022

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: 04/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/04/2022
• Date Device Manufactured: 10/15/2021
• 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: 78 YR
• Patient Sex: Male