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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Activa Deep Brain Stimulation System

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  Class 2 Device Recall Medtronic Activa Deep Brain Stimulation System see related information
Date Initiated by Firm November 30, 2005
Date Posted January 10, 2006
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-0370-06
Recall Event ID 34156
PMA Number P960009 
Product Classification Stimulator, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
Product 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 is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System.
Code Information All serial numbers and Lot codes are affected.
Recalling Firm/
Manufacturer		 Medtronic Inc, Neurological & Spinal Division
800 53rd Ave Ne
Columbia Heights MN 55421-1241
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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