BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRT-D

    MDR report key: 3795507 · Received May 2, 2014

    Report

    Report Number
    MW5035936
    Event Type
    Death
    Date Received
    May 2, 2014
    Date of Event
    September 10, 2012
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I'M CAREGIVER AND THAT PT WENT INTO CARDIAC ARREST AND THE PACEMAKER DEVICE DID NOT WORK. WHEN THE PT'S HEART STARTED TO FAIL AND SHE SUFFERED. THE PACEMAKER NEVER WORKED, CAUSED DAMAGE TO BRAIN AND HEART, KIDNEYS. DUE TO EMERGENCY ROOM, DOCTOR DELAY, PT WENT INTO CARDIAC ARREST, WENT ON LIFE SUPPORT. DOCTOR TOOK PT TO SURGERY TO REPAIR TWO CLOTS TO UNBLOCK PREVIOUS STENT AND THE HEART PUMP WAS INSERTED INCORRECTLY. IT FAILED, NEVER SHOWING READING. THE PT SUFFERED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263760 CRT-D CRT-D LWS MEDTRONIC D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death