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.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- November 19, 2020
- Terminated
- April 3, 2023
- Recall Number
- Z-0612-2021
- Quantity
- 12 devices
- Firm Location
- Minneapolis, MN
Reason for Recall
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Distribution
US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Lot / Code Info
Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
Root Cause
Software design
Action Taken
Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product. Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives.