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Vercise genus r16 and r32 ipg kits

Official notice

25 Apr 2024

Last checked

25 Apr 2024

Medium riskHealth Canada
Watch Boston Scientific Neuromodulation

An official Health Canada notice concerns Vercise genus r16 and r32 ipg kits. Boston Scientific has received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. Recall Start Date: April 18, 2024 Published 2024-04-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75445

Official notice

2024-04-25

The hazard

Boston Scientific has received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. Recall Start Date: April 18, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75445

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Affected products

Product 1

Affected products - Vercise Genus R16 IPG Kit, Lot or serial number - 100209 - 753347, Model or catalog number - DB-1216

Product 2

Affected products - Vercise Genus R32 IPG Kit, Lot or serial number - 100104 - 753200, Model or catalog number - DB-1232

Risk / hazard

Boston Scientific has received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. Recall Start Date: April 18, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Boston Scientific Neuromodulation, Vercise Genus R16 And R32 Ipg Kits

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific Neuromodulation, Vercise Genus R16 And R32 Ipg Kits.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75445

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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