Recall Z-0612-2021— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2020-11-19, terminated 2023-04-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-19
- Terminated
- 2023-04-03
- Firm location
- Minneapolis, MN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.