BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3022049 · Received March 26, 2013

    Report

    Report Number
    3022049
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 25, 2013
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUSPECTED RVAD THROMBUS POWER ALRMS 6-7.LDH 600'S, STARTED ON BIVALRUDIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124495 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1