—#129036

Product

Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009S052
Affected lot / code info: Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.

Why it was recalled

Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.

Root cause (FDA determination)

Process control

Action the firm took

The firm, Medtronic, notified their Consignees on 07/14/2014 via telephone of the recall. Medtronic representative used telephone script to convey the information. The script was directed to Risk Management or Inventory Management. The caller was to inform consignees of the problem and product being recalled. Advised consignees to quarantine the product and provided the Medtronic Device Removal Reply Form to the consignees via e-mail or Fax. The Reply Form included contact information which was to call 1-800-633-8766 in case they needed to contact a Medtronic representative. The completed form is to be faxed back to 1-800-897-3899 or e-mail a PDF to neuro.quality@medtronic.com. If you have any questions, call 763-526-1294.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the states of: MA, NC, OH, and TX.

Timeline

Recall initiated: 2014-07-14
Posted by FDA: 2014-08-18
Terminated: 2014-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129036. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.