Device product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Z-0217-2024
Product summary
- Event
- Event 93170
- Status
- Completed
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-0217-2024
Official wording
Reason: There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Code information: UDI/DI 00763000274320, Serial Number VA2JV2V
Distribution pattern: US: MO, FL, TX, WA
Derived failure modes
-
Unknown
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.