Device product
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
Z-1527-2021
Product summary
- Event
- Event 87662
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37690 units
- Official record key
device-enforcement:Z-1527-2021
Official wording
Reason: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Code information: all codes
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.