—#147876

Product

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: lots: VA15GPJ, VA15K3N, VA15K7K

Why it was recalled

Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.

Root cause (FDA determination)

Process design

Action the firm took

Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave, Minneapolis, Minnesota 55421-1241

Distribution

Distribution pattern: US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

Timeline

Recall initiated: 2016-06-10
Terminated: 2016-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.