Health product recall

Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator

Brand(s)
Last updated

Summary

Product
Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator

More than 10 numbers, contact manufacturer.

B35200

Issue

Medtronic has determined that in rare instances (0.044%) the Percept™ PC implantable neurostimulator (INS) model B35200 cannot communicate with the clinician programmer and/or the patient programmer system (HH90 handset and TM91 communicator). In these instances, the INS will continue to provide therapy to the patient within programmed parameters. While the occurrence is rare, Medtronic is raising awareness to inform and serve our customers. since the launch of Percept PC in January 2020 through the end of February 2022, Medtronic has received six (6) confirmed reports of this issue. Five (5) of these reported events occurred within the United States and one (1) event occurred in Switzerland. Two devices were explanted as a result of not being able to connect with the INS Medtronic can perform an ins diagnostic and communication reset should this issue occur and is investigating changes to prevent the occurrence.

Recall start date: Mar 29, 2022

Additional information

Details
Original published date: 2022-04-13
Alert / recall type
Health product recall
Category
Health product - Medical device - Neurology
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-64074