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 - Performance issue
What to do

Immediately stop using the product and contact manufacturer.

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 Cardioversion may damage the electronics in the Percept PC INS device, making the INS unresponsive and non-functional, meaning that the INS cannot be turned back on. To restore stimulation therapy, surgical replacement of the INS will be required. Cessation of therapy will likely cause a return of disease symptoms. In some cases, symptoms may return with an intensity greater than was experienced prior to implant (rebound effect). In rare cases, this can constitute a medical emergency.

 

Recall date: 2021-10-14

Additional information

Details
Original published date: 2021-11-03
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-63534