Device product
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
Z-0612-2021
Product summary
- Event
- Event 86907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-0612-2021
Official wording
Reason: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Code information: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
Distribution pattern: US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Derived failure modes
-
Device software or design
software anomaly