Recall Z-0418-2022 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
| Date | Oct 19, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Medtronic distributed a correction notice via mail courier service to impacted U.S. consignees, delivered 06-October-2021. A second attempt to notify US consignees is scheduled for the week of 08-November-2021. A third attempt to notify US consignees is scheduled for the week of 10-Jan-2022. In addition to Medtronic s communications to Percept PC implanting and managing physicians, Medtronic will notify affected patients implanted with Percept PC INS devices of this issue in the US. US Patient notifications are scheduled to happen within a month s timeframe. Medtronic will retain delivery co |
| Quantity | 10,006 units |
| Distribution | Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.