BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE CHF GENERATOR

    MDR report key: 1683753 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-05334
    Event Type
    Death
    Date Received
    May 7, 2010
    Report Date
    July 27, 2010
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAVE TO DISK AND MEMORY DUMP WERE ANALYZED. THE DEVICE HAD PERFORMED 3 WARM RESETS. THE LIKELY CAUSE OF THESE RESETS IS CRC DETECTED MEMORY CORRUPTION. SYSTEM BLOCK FIX COUNT IS ALSO SET TO 3 WHICH INDICATES THAT CORRUPTION HAS BEEN DETECTED AND CORRECTED 3 TIMES IN PG PROGRAMMED PARAMETER BLOCKS. THERE WERE NO HISTORY RELATED FAULTS NOTED. HOURLY RAM CHECKS WERE RUN AND VERIFIED THE INTEGRITY OF THAT PORTION OF MEMORY. THE OBSERVATION RELATED TO THE LV COUNTERS APPEARS TO BE DUE TO A SINGLE BIT CORRUPTION IN THE 9TH LIFETIME LV PACE HISTOGRAM BIN. THIS HISTOGRAM CORRUPTION CANNOT BE CORRECTED, BUT "SINCE LAST RESET" COUNTERS AND HISTOGRAM DATA CAN BE USED TO EVALUATE DEVICE PERFORMANCE IN THE FUTURE ONCE THE USER RESETS COUNTERS. THE HCP SHOULD MONITOR THIS PATIENT PER THE BSC RADIATION GUIDELINES. AT THIS TIME, THE DISPOSITION OF THIS DEVICE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT RADIATION. ALL COMMANDED DIAGNOSTICS WERE SHOWING 'NOT RECORDED' EXCEPT FOR SHOCK IMPEDANCE MEASUREMENTS. THERE WERE SOME ELEVATED LEFT VENTRICULAR (LV) PACING. TECHNICAL SERVICES (TS) INDICATED THAT THIS APPEARS TO BE A RESET AND REQUESTED A SAVE TO DISK AND MEMORY DUMP BE SUBMITTED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS PATIENT PASSED AWAY. AT THIS TIME, THE CAUSE OF DEATH IS UNKNOWN AND NO PERFORMANCE ALLEGATIONS HAVE BEEN REPORTED. IT WAS NOTED THAT THE PATIENT RECEIVED SEVERAL SHOCKS AT THE TIME OF DEATH. SUBSEQUENT INFORMATION FROM THE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT PASSED AWAY AT HOME. ACCORDING TO THE PATIENT'S SPOUSE, THE PATIENT DID RECEIVE SHOCKS; HOWEVER, IT IS UNKNOWN IF IT WAS BEFORE, DURING OR AFTER THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CHF GENERATOR NIK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death