Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator

Medtronic has determined that in rare instances (0.044%) the Percept™ PC implantable neurostimulator (INS) model B35200 cannot communicate with the clinician programmer and/or the patient programmer system (HH90 handset and TM91 communicator). In these instances, the INS will continue to provide therapy to the patient within programmed parameters. While the occurrence is rare, Medtronic is raising awareness to inform and serve our customers. since the launch of Percept PC in January 2020 through the end of February 2022, Medtronic has received six (6) confirmed reports of this issue. Five (5) of these reported events occurred within the United States and one (1) event occurred in Switzerland. Two devices were explanted as a result of not being able to connect with the INS Medtronic can perform an ins diagnostic and communication reset should this issue occur and is investigating changes to prevent the occurrence.

Recall start date: Mar 29, 2022