Device Dossier
EMBLEM™ S-ICD Subcutaneous Electrode Model 3501 - Lead, defibrillator, implantable
Device Dossier for EMBLEM™ S-ICD Subcutaneous Electrode Model 3501 - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III,…
- GMDN category: Lead, defibrillator, implantable
Intended purpose
The EMBLEM™ S-ICD subcutaneous electrode 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 subcutaneous electrode includes one high voltage shock electrode coil to provide defibrillation energy. Defibrillation is delivered between the coil on the subcutaneous electrode & the electrically conductive pulse generator case. Sensing occurs between 2 electrically conductive rings on the subcutaneous electrode or between either of the rings on the subcutaneous electrode & the electrically conductive pulse generator case.