Device product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Z-1173-2024
Product summary
- Event
- Event 93791
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,469 total units
- Official record key
device-enforcement:Z-1173-2024
Official wording
Reason: OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
Code information: OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.
Distribution pattern: Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Derived failure modes
-
Unknown
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.