ENPATH

Additional Manufacturer Narrative

A REQUEST WAS MADE FOR PRODUCT RETURN. INVESTIGATION HAS BEEN COMPLETED TO THIS POINT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DEFIBRILLATION, AND TRANSVENOUS LEADS WERE EXPLANTED. THE LEFT VENTRICULAR LEAD, REQUIRING AND ADAPTER, WAS CUT AND SURGICALLY ABANDONED. THIS ALL OCCURRED DUE TO A PATIENT'S INFECTION AND EROSION RELATED TO THESE PRODUCTS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.