Device product
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
Z-0079-2018
Product summary
- Event
- Event 78323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-0079-2018
Official wording
Reason: The devices have an incorrect firmware configuration.
Code information: Serial numbers 174170, 174349, 174598, and 174606.
Distribution pattern: The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Derived failure modes
-
Device software or design
incorrect firmware