—#51935

Product

Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009S036
Affected lot / code info: V026775

Why it was recalled

Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).

Root cause (FDA determination)

Other

Action the firm took

Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.

Timeline

Recall initiated: 2007-04-16
Posted by FDA: 2007-06-15
Terminated: 2008-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.