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Vercise genus ™ r16 and r32 implantable pulse generator (ipg) kits
Official notice
12 Aug 2024
Last checked
12 Aug 2024
An official Health Canada notice concerns Vercise genus ™ r16 and r32 implantable pulse generator (ipg) kits. Manufacturer is initiating an advisory to remind customers to follow steps outlined in the labeling/instructions for use to implant Vercise Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Device header feedthrough (FT) wire break(s) have occurred in rechargeable Vercise Genus ™ DBS IPGs that were implanted submuscular in the pectoral location. Manufacturer has not received reports of FT wire breaks with Vercise Genus ™ DBS IPGs implanted in a subcutaneous pocket. Complete or partial breaks of device header FT wire(s) will prevent successful delivery of stimulation therapy, thus requiring removal/replacement of the device. Clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or bluetooth connectivity challenges may be potential signals associated with FT wire break(s). Recall start date: August 8, 2024 Published 2024-08-12.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75912
Official notice
2024-08-12
The hazard
The hazard
Manufacturer is initiating an advisory to remind customers to follow steps outlined in the labeling/instructions for use to implant Vercise Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Device header feedthrough (FT) wire break(s) have occurred in rechargeable Vercise Genus ™ DBS IPGs that were implanted submuscular in the pectoral location. Manufacturer has not received reports of FT wire breaks with Vercise Genus ™ DBS IPGs implanted in a subcutaneous pocket. Complete or partial breaks of device header FT wire(s) will prevent successful delivery of stimulation therapy, thus requiring removal/replacement of the device. Clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or bluetooth connectivity challenges may be potential signals associated with FT wire break(s). Recall start date: August 8, 2024
How to check if you're affected
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.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Brand: Boston Scientific Neuromodulation, Vercise Genus ™ R16 And R32 Implantable Pulse Generator Kits.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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