BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRT-D

    MDR report key: 3027438 · Received March 22, 2013

    Report

    Report Number
    MW5029504
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    March 24, 2011
    Report Date
    March 22, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MORNING OF (B)(6) 2011, (B)(6) WENT INTO THE HOSPITAL DUE TO A BRONCHIAL INFECTION. AFTER MULTIPLE ISSUES IN STABILIZING HIS BLOOD SUGAR AND REDUCING THE WATER IN HIS LUNGS, HIS HEART WEAKENED. ON (B)(6) 2011, A PACE MAKER / DEFIBRILLATOR CRT-D FROM ST. JUDE MEDICAL WAS IMPLANTED. THE PACE MAKER WORKED FINE, BUT THE DEFIBRILLATOR WAS MALFUNCTIONING AND CONSTANTLY SHOCKING HIS HEART. ON (B)(6), THE CARDIOLOGIST ATTEMPTED TO PERFORM A PROCEDURE TO CALIBRATE THE ISSUE WITH THE DEFIBRILLATOR. THE PROCESS WAS UNSUCCESSFUL. ON (B)(6), AFTER (B)(6) DAYS OF CONTINUAL SHOCKS ON HIS HEART, (B)(6) WENT INTO CARDIAC ARREST, REMAINING IN THE CRITICAL CARE UNIT. AFTER HE WAS REVIVED AND STABILIZED, IT WAS LEARNED HIS ORGANS HAD FULLY DROWNED WITHIN HIS BODY FLUIDS. ON (B)(6), HE WAS TRANSPORTED TO (B)(6). ONCE SETTLED INTO A ROOM, A MEDICAL TECHNICIAN TURNED OFF THE DEFIBRILLATOR DEVICE SO (B)(6) COULD REST WITHOUT CONTINUAL SHOCK WAVES PENETRATING HIS HEART. HE PASSED AWAY (B)(6) HOURS AGO. DATES OF USE: (B)(6) 2011 (SIX DAYS). DIAGNOSIS OR REASON FOR USE: REGULATE HEART STRENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119361 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NIK ST. JUDE MEDICAL UNIFY 3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| O| R