Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
Hazard
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).
What You Should Do
Remedy
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.
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Products
Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
- Brand
- Medtronic Neuromodulation
- UPC
- V026775
Units Affected
31 kits