PATCH

Description of Event or Problem

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO EPICARDIAL LARGE PATCH LEADS WERE EXHIBITING HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND LOW OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. THE EPICARDIAL PATCHES HAVE BEEN IMPLANTED FOR APPROXIMATELY 19 YEARS. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED PERFORMING A 1.1 AND 41 JOULE SHOCK TO TEST THE INTEGRITY OF THE SYSTEM AND THE DEVICE'S ABILITY TO DELIVER A SHOCK. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

Additional Manufacturer Narrative

ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT PLANNED TO BE MONITORED. THERE WERE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME.

Description of Event or Problem

APPROXIMATELY TWO YEARS LATER THE EPICARDIAL PATCH WAS RETURNED FOR ANALYSIS DUE TO A PATIENT DEATH FROM CONGESTIVE HEART FAILURE.

Additional Manufacturer Narrative

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED LEAD SEGMENT WAS PERFORMED.THE LEAD WAS SEVERED 27.6 CM FROM THE TERMINAL PIN, AND ONLY THE PROXIMAL SEGMENT WAS RETURNED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.