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Health Canada Medical devices

PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR

Issued October 29, 2021
Issue
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
Hazard description
Performance
Product
Product name
PERCEPT PC BRAINSENSE DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR
Reference
ID
RA-63534