EMBLEM™ MRI S-ICD Model A219 - Defibrillator, implantable, automatic

Intended purpose

The EMBLEM™ MRI S-ICD pulse generator is a component of the Boston Scientific S-ICD System. 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.

Functional description

The pulse generator contains the electrical components and firmware implemented algorithm used to analyze sensed cardiac signals in order to determine if defibrillation therapy should be delivered or inhibited. A header on the pulse generator is designed to mate exclusively with the Subcutaneous Electrode and also contains the antenna used to facilitate RF telemetry communications with the Programmer.