IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

Description of Event or Problem

IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ABLE TO INTERROGATE AS THIS ICD WAS A NON-CONDITIONAL MAGNETIC RESONANCE IMAGING (MRI) PROTOCOL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS ICD MIGHT HAVE DEPLETED. THIS ICD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ABLE TO INTERROGATE AS THIS ICD WAS A NON-CONDITIONAL MAGNETIC RESONANCE IMAGING (MRI) PROTOCOL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS ICD MIGHT HAVE DEPLETED. THIS ICD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.