Recall Z-2259-2014 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted sub
| Date | Aug 18, 2014 (initiated Jul 14, 2014) |
| Status | Terminated |
| Reason | Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. |
| Root cause | Process control |
| Action | The firm, Medtronic, notified their Consignees on 07/14/2014 via telephone of the recall. Medtronic representative used telephone script to convey the information. The script was directed to Risk Management or Inventory Management. The caller was to inform consignees of the problem and product being recalled. Advised consignees to quarantine the product and provided the Medtronic Device Removal Reply Form to the consignees via e-mail or Fax. The Reply Form included contact information which was to call 1-800-633-8766 in case they needed to contact a Medtronic representative. The completed fo |
| Quantity | 6 |
| Distribution | Distributed in the states of: MA, NC, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.