Recall Z-0612-2021 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
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.
| Date | Nov 19, 2020 |
| Status | Terminated |
| Reason | A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 12 devices |
| Distribution | US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.