PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR

Medtronic has determined that Cardioversion may damage the electronics in the Percept PC INS device, making the INS unresponsive and non-functional, meaning that the INS cannot be turned back on. To restore stimulation therapy, surgical replacement of the INS will be required. Cessation of therapy will likely cause a return of disease symptoms. In some cases, symptoms may return with an intensity greater than was experienced prior to implant (rebound effect). In rare cases, this can constitute a medical emergency.

Recall date: 2021-10-14