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.
Reported: December 23, 2020 Initiated: November 19, 2020 #Z-0612-2021
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 12 devices
- Distribution
- US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 12 devices.
Why was this product recalled? ▼
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0612-2021.
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