Submuscular implantation of Vercise Genus™ Deep Brain Stimulation Implantable Pulse Generators with feedthrough wire break(s)

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to remind healthcare professionals to follow the steps outlined in the labeling/Instructions for Use (IFU) to implant Vercise Genus^TM 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^TM DBS IPGs that were implanted submuscular in the pectoral location. The root cause investigation for the FT wire breaks has determined that the use of a submuscular implant technique in the pectoral region can lead to additional, frequent muscle tension forces on an IPG against the patient’s ribs, especially if the device is sutured to the muscle, ultimately resulting in device header FT wire break(s). These repetitive stresses are not applicable for an IPG 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. Healthcare professionals are advised to follow existing device labeling/IFU regarding implant location within a subcutaneous pocket when implanting the IPGs. For any patient with a rechargeable Vercise Genus DBS IPG implanted submuscular in the pectoral region, a patient letter is enclosed to share with the patient. It is also recommended to monitor these patients for clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and / or Bluetooth connectivity challenges which may be potential signals associated with FT wire break(s). Please refer to the letter for details.

Published: 20 Aug 2024

Dear Healthcare Professional Letters