PATCH

Additional Manufacturer Narrative

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM INFECTION. AN EXPLANT PROCEDURE WAS PERFORMED AND THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ENDOCARDIAL TRANSVENOUS LEADS WERE EXTRACTED. THIS PRODUCT HAD BEEN PREVIOUSLY CAPPED AND STILL REMAINS IMPLANTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.