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