BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRACOR LVAD

    MDR report key: 1063115 · Received June 20, 2008

    Report

    Report Number
    1063115
    Event Type
    Death
    Date Received
    June 20, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 18, 2008
    Manufacturer
    VENTRACOR INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MALE, ENROLLED IN THE VENTRASSIST LVAD STUDY, UNDERWENT PLACEMENT OF VENTRASSIST LVAD DEVICE IN 2008. WHILE AT HOME, AT ABOUT APPROX 5 WEEKS LATER, THE PATIENT WAS FOUND UNRESPONSIVE. POLICE ARRIVED AND NOTED THAT THE EXTERNAL POWER PACK WAS NOT CONNECTED TO THE PATIENT'S EXTERNAL DEVICE LEAD. MEDICAL EXAMINER PRONOUNCED THE PATIENT AT 00:53 THAT DAY. AUTOPSY RESULTS ARE PENDING. BLOODPUMP 314183.0100495. EXTRACORPOREAL LEAD 322874.00075. CONTROLLER 299125.00678.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRACOR LVAD DESTINATION VENTRACOR LVAD BLOODPUMP DSQ VENTRACOR INC. 314183 0100495
    2 VENTRACOR LAVAD DESTINATION VENTRACOR LVAD EXTRACORPOREAL LEAD DSQ VENTRACOR INC. 322874 00075
    3 VENTRACOR LAVAD DESTINATION VENTRACOR LVAD CONTROLLER DSQ VENTRACOR INC. 299125 00678

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death