No image published for this recall

No image published for this recall

Percept pc brainsense deep brain stimulation implantable neurostimulator

Official notice

29 Oct 2021

Last checked

29 Oct 2021

Medium riskHealth Canada

An official Health Canada notice concerns Percept pc brainsense deep brain stimulation implantable neurostimulator. 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 Published 2021-10-29.

What to do now

Immediately stop using the product and contact manufacturer.

Recall number

63534

Official notice

2021-10-29

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63534

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Affected products

Product 1

Affected Products - PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - B35200

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Medtronic, Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63534

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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