BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3112556 · Received May 14, 2013

    Report

    Report Number
    3112556
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    THORATEC CORPORATION
    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

    DESPITE CONTINUOUS IV ANTICOAGULATION, PT DEVELOPED PUMP THROMBUS WITH ELEVATED LDH,HPF. TPA WAS ADMINISTERED WHICH RESULTED IN HEMORRHAGIC CVA AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212505 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death