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Health Canada Medical devices

Vercise Genus R16 and R32 IPG Kits

Issued April 25, 2024
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
Hazard description
Performance
Product
Product name
Vercise Genus R16 and R32 IPG Kits
Reference
ID
RA-75445