Device product
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Z-1463-2021
Product summary
- Firm
- BIOTRONIK Inc
- Event
- Event 87549
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 UNITS
- Official record key
device-enforcement:Z-1463-2021
Official wording
Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Code information: Serial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228
Distribution pattern: US: Nationwide OUS: Worldwide
Derived failure modes
-
Unknown
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)