Device product
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Z-1465-2021
Product summary
- Firm
- BIOTRONIK Inc
- Event
- Event 87549
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 UNITS
- Official record key
device-enforcement:Z-1465-2021
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 84737505 84737521 84738497 84738498 84738995 84738997 84739001 84739004
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)