Device product
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Z-1512-2020
Product summary
- Event
- Event 85077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 device
- Official record key
device-enforcement:Z-1512-2020
Official wording
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Code information: Serial Number 516959
Distribution pattern: US Nationwide distribution in the states of NC, TN, and MO.
Derived failure modes
-
Unknown
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.