KSS if 4-Site
Purpose of Research
The objective of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of a 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-Site ENDOTAK RELIANCE defibrillation lead connected to a 4-SITE Header of a single or dual chamber implanted cardioverter defibrillator or cardiac resynchronization therapy ICD pulse generator.
Patients who are asked to participate in this study are people who have an FDA Boston Scientific CRM implantable device system to regulate their heart.