Device product
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Z-2602-2016
Product summary
- Event
- Event 74545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70
- Official record key
device-enforcement:Z-2602-2016
Official wording
Reason: 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.
Code information: lots: VA15GPJ, VA15K3N, VA15K7K
Distribution pattern: US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Derived failure modes
-
Unknown
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.