BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3241144 · Received July 22, 2013

    Report

    Report Number
    3241144
    Date Received
    July 22, 2013
    Date of Event
    July 6, 2013
    Report Date
    July 15, 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

    ACUTE ELEVATION IN PLASMA HEMOGLOBIN AND SUSPECTED PUMP THROMBUS WITH RENAL AND HEPATIC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341608 HEARTMATE II LVAS BIVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death REVOLUTION - RVAD