Recall Z-0418-2022— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2021-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Model B35200 - Percept PC BrainSense Implantable Neurostimulator. Reason: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-19
- Firm location
- Minneapolis, MN, United States
Product description
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Reason for recall
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Data sourced from openFDA. This site is unofficial and independent of the FDA.