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Medtronic Activa Deep Brain Stimulation (DBS) system… recallZ-0370-06 · Medtronic Inc, Neurological & Spinal Division · initiated Nov 30, 2005

Terminated All recalls posted in January 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc, Neurological & Spinal Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0370-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 30, 2005
Posted by the FDA
Jan 10, 2006
Recalling firm
Medtronic Inc, Neurological & Spinal Division
Product code
MHY
FDA submissions
P960009
Distribution
Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America

Product description

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 (models, lots, serial numbers)

All serial numbers and Lot codes are affected.

Other devices under the same FDA submission

90 devices cleared under P960009 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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