Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neur

FDA device recall Z-0370-06 · posted 2006-01-10 · Terminated

Recall details

Recalling firm

Medtronic Inc, Neurological & Spinal Division

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MHY

Distribution

Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America

Date initiated

2005-11-30

Date posted

2006-01-10

Date terminated

2006-12-28

Location

Columbia Heights, MN