Health product recall

Interstim Percutaneous Extension

Brand(s)
Last updated

Summary

Product
Interstim Percutaneous Extension
Issue
Medical devices - Increased risk or new adverse events
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Interstim Percutaneous Extension

All lots.

3560030, 3560022

Issue

Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the percutaneous extension connector after the evaluation period when it is necessary to remove the percutaneous extension and external neurostimulator (ENS). In some cases of reported migration, an additional incision along the tunneling pathway has been required to disconnect the lead from the percutaneous extension. Patients may also be at an increased risk of procedural complications due to delays associated with troubleshooting. Additionally, if the chronic lead is damaged or displaced during the explant of the percutaneous extension, intraoperative replacement of the lead or an additional surgical procedure may be needed.

Recall start date: Mar 10, 2021

Additional information

Details
Original published date: 2022-01-25
Alert / recall type
Health product recall
Category
Health product - Medical device - Gastroenterology & Urology
Companies

Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota

United States, 55432

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63862