BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3200382 · Received July 1, 2013

    Report

    Report Number
    3200382
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 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

    THE PT DEVELOPED CHEST PAIN, WENT TO (B)(6), THE VAD WAS CLOTTED OFF, BUT SHE WAS HEMODYNAMICALLY STABLE, SO THE VAD WAS TURNED OFF, SHE WAS PLACED ON DOBUTAMINE AND SWAN INDICATED ADEQUATE CI. REMAINS WITH PUMP OFF IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299028 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1