—#135848

Product

Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: all Serial numbers

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 CST.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2015-04-16
Posted by FDA: 2015-05-15
Terminated: 2016-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.