Description of Event or Problem · 1
PT WAS DISCHARGED IN 03/2002. DR SPOKE TO PT'S SPOUSE. PT'S SPOUSE FOUND PT DEAD IN THE MORNING. PT HAD APPARENTLY DIED IN THEIR SLEEP. DEVICE WAS INTERROGATED WHICH FOUND NO ARRHYTHMIC EVENT. AN AUTOPSY IS PENDING. THE DEVICE WAS INTERROGATED BY GUIDANT'S RELIABILITY ASSURANCE LAB AND WAS FOUND WITH A BATTERY STATUS OF BOL AND A CORRESPONDING MONITORING VOLTAGE OF 3.21 VOLTS. THE DEVICE WAS PUT THROUGH A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, MEMORY AND RECORDING FUNCTIONS OF THE DEVICE. ALL SEAL PLUGS WERE INTACT AND SET SCREWS MOVED FREELY. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS AND MET SPECS APPROPRIATE FOR BATTERY STATUS. ANALYSIS OF STORED DATA DID NOT IDENTIFY ANY FAULT CODE OR ERROR MESSAGES. ATRIAL AND VENTRICULAR LEAD IMPEDANCES AND VENTRICULAR SHOCKING IMPEDANCE TWO DAYS BEFORE DEATH WERE WITHIN ACCEPTABLE TOLERANCES. CAPACITOR CHARGE TIMES WERE WITHIN NORMAL LIMITS. NO PACING THRESHOLDS OR INTRINSIC AMPLITUDE TESTS WERE PERFORMED DUE TO THE PT'S PACEMAKER DEPENDENCY. EPISODE#1 DETAILS AN INDUCED VENTRICULAR ARRHYTHMIA WITH SUCCESSFUL DEFIBRILLATION AT 41 JOULES AND A CORRESPONDING SHOCKING IMPEDANCE OF 28 OHMS. NO VF UNDERSENSING WAS OBSERVED DURING INDUCTION TESTING. ARIAL AND VENTRICULAR PACING (DDDR) WITH CAPTURE WAS DOCUMENTED POST-SHOCK THERAPY. INTERMITTENT FAR-FIELD VENTRICULAR SENSING (WITHIN BLANKING) FOLLOWING AN ATRIAL PACED EVENT WAS NOTED, HOWEVER, NO PACING INHIBITION WAS EVIDENT. NO SPONTANEOUS ARRHYTHMIAS WERE IDENTIFIED SUBSEQUENT TO IMPLANT TESTING. THE VENTRICULAR LEAD IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THE COMPETITOR ATRIAL LEAD WAS NOT RETURNED TO GUIDANT FOR ANALYSIS.