Device product
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Z-3037-2017
Product summary
- Event
- Event 77803
- Status
- Terminated
- Classification
- Class II
- Quantity
- Approximately 16,750 devices
- Official record key
device-enforcement:Z-3037-2017
Official wording
Reason: The device can deliver an atypical amount of energy due to memory corruption inside the device.
Code information: All serial numbers
Distribution pattern: Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Derived failure modes
-
Unknown
The device can deliver an atypical amount of energy due to memory corruption inside the device.