BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT VR

    MDR report key: 4170505 · Received September 23, 2014

    Report

    Report Number
    4170505
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    May 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEATH. PATIENT HAD A CARDIAC ARREST IN THE ICU UNIT. AFTER CPR HAD BEEN DONE FOR 30 MINUTES, AND AN ECHO SHOWED NO WALL MOTION, IT WAS FELT THAT THE DEFIBRILLATOR SHOULD BE TURNED OFF. THEREFORE, THE CARDIOLOGIST PROGRAMMED THE DEFIBRILLATOR OFF AND THE PACEMAKER TO OVO. THE PATIENT WENT BACK INTO VENTRICULAR FIBRILLATION. THE PATIENT DID CODE AGAIN AND THEN EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591749 EVERA XT VR GENERATOR DTE MEDTRONIC INC. DVBBID4

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death