SMALL PATCH DF-1 SUTURE UNI 67CM

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND CHRONIC EPICARDIAL PATCH DEFIBRILLATION LEADS WERE MEASURING A SHOCK IMPEDANCE OF GREATER THAN 125 OHMS. A TRIAD SHOCKING VECTOR DID NOT CONVERT THE PATIENT AT 21 J, AND THE PHYSICIAN REPORTEDLY BELIEVES THIS WAS DUE TO A DEVICE FAILURE. THE SHOCK VECTOR WAS REPROGRAMMED COIL TO COIL, RESULTING IN SUCCESSFUL CONVERSION AT 21 J. THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT DISCUSSED THE POSSIBILITY OF DEFIBRILLATION LEAD PINS BEING REVERSED IN THE HEADER, A LEAD FRACTURE, OR A CONNECTION ISSUE. TECHNICAL SERVICES RECOMMENDED A 41 J AND 1.1 J COMMANDED SHOCK TO MEASURE LEAD IMPEDANCES AND TO VERIFY THERAPY DELIVERY. THE FOLLOWING CLINIC BROUGHT THE PATIENT IN FOR TROUBLESHOOTING AND DEFIBRILLATION THRESHOLD (DFT) TESTING. A 31 J SHOCK WAS DELIVERED, WHICH SUCCESSFULLY CONVERTED THE PATIENT. SHOCK IMPEDANCE MEASUREMENTS FOR THE SHOCK WERE WITHIN NORMAL RANGE, BUT RETURNED TO >125 OHMS, APPROXIMATELY 5 MINUTES LATER. AT THIS TIME, THE PHYSICIAN HAS NOT ELECTED TO PERFORM ANY ADDITIONAL REPROGRAMMING OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS PROVIDED THAT ADDITIONAL OUT OF RANGE SHOCK IMPEDANCES WERE NOTED BY THE PATIENT'S CLINIC. IT WAS NOTED THAT THE CLINIC WAS ALREADY AWARE OF THIS ONGOING ISSUE AND WAS ELECTING TO CONTINUE MONITORING THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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.