Device product
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)
Z-1523-2021
Product summary
- Event
- Event 87654
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45,411 devices
- Official record key
device-enforcement:Z-1523-2021
Official wording
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Code information: all serial numbers
Distribution pattern: Worldwide
Derived failure modes
-
Device software or design
software issue