Recall Z-0370-06 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Inc, Neurological & Spinal Division
Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System
| Date | Jan 10, 2006 (initiated Nov 30, 2005) |
| Status | Terminated |
| Reason | A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. The recommended maximum displayed head SAR is now 0.1 W/kg. |
| Root cause | Other |
| Action | The firm''s recall consists of providing revised instructions for the Activa DBS. The revision modifies the recommended SAR to use during MRI of patients who have an Activa DBS. Use of the Activa DBS is otherwise unaffected by this recall. A Dear Healthcare Provider letter and MRI Radiologist letter were sent on 11/30/05 and 12/05/05 to provide this information. |
| Distribution | Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.