PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR
Immediately stop using the product and contact manufacturer.
|Lot or serial number
|Model or catalog number
|PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR
|More than 10 numbers, contact manufacturer.
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
710 MEDTRONIC PARKWAY N.E.,