Vercise Genus R16 and R32 IPG Kits
Last updated
Summary
Product
Vercise Genus R16 and R32 IPG Kits
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vercise Genus R16 IPG Kit | 100209 - 753347 | DB-1216 |
| Vercise Genus R32 IPG Kit | 100104 - 753200 | DB-1232 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, California, United States, 91355
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75445
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