BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRT-D

    MDR report key: 3032563 · Received March 29, 2013

    Report

    Report Number
    MW5029560
    Event Type
    Death
    Date Received
    March 29, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), (B)(6) WENT INTO THE HOSPITAL FOR A BRONCHIAL INFECTION. AFTER A SERIES OF EVENTS TO STABILIZE HIS SUGAR LEVEL AND MINIMIZE WATER RETENTION, IT WAS MEDICALLY RECOMMENDED THAT HE HAVE A CARDIAC PACE-MAKER/DEFIBRILLATOR INSERTED. THIS PROCEDURE WAS DONE ON (B)(6). THE PACE-MAKER FUNCTIONED FINE, BUT THE DEFIBRILLATOR WAS CONSTANTLY SENDING SHOCK WAVES INTO HIS HEART. ON (B)(6), THE CARDIOLOGIST ATTEMPTED TO RE-CALIBRATE THE UNIT. AS A RESULT, THE DEFECTIVE MECHANISM CONTINUED THE SHOCK SESSION TO THE HEART. ON (B)(6), (B)(6) WENT INTO CARDIAC ARREST. AFTER HE WAS REVIVED AND STABILIZED, THE DIAGNOSIS WAS NOT FAVORABLE DUE TO HIS ORGANS BEING DROWNED IN HIS BODY FLUIDS. (B)(6) WAS TAKEN TO HOSPICE CARE ON (B)(6). AFTER SETTLING HIM INTO A ROOM, WITHIN 10 MINUTES A MEDICAL TECHNICIAN WAS ABLE TO TURN OFF THE DEFIBRILLATING DEVICE SO HE COULD REST WITHOUT PAIN. THE TECHNICIAN ADVISED US THAT 1 OUT OF 36 OF THESE UNITS WERE DEFECTIVE AND RECOMMENDED THAT WE RETAIN IT FOR FUTURE EVALUATION. (B)(6) DIED 36 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129778 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, HIGH VOLTAGE NIK ST. JUDE MEDICAL UNIFY RV/SVC (SJ4-LLHH)

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| O| R| S NO OTHERS