Recall Z-1617-2015 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
| Date | May 15, 2015 (initiated Apr 16, 2015) |
| Status | Terminated |
| Reason | Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603). |
| Root cause | Under Investigation by firm |
| Action | Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to neuro.quality@medtronic.com. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm C |
| Quantity | 86,851 (US 37,933 / OUS 48,918) |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.