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Vercise genus ™ r16 and r32 implantable pulse generator (ipg) kits
Official notice
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
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How to check if you're affected
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Brand: Boston Scientific Neuromodulation, Vercise Genus ™ R16 And R32 Implantable Pulse Generator Kits.
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