BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2997811 · Received March 11, 2013

    Report

    Report Number
    2997811
    Event Type
    Death
    Date Received
    March 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 11, 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

    PATIENT ADMITTED FOR POSSIBLE PNEUMONIA / HEMOLYSIS. (B)(4) STUDY DONE DURING ADMISSION REVEALING INFLOW CANNULA THROMBUS. PATIENT NOT SURGICAL CANDIDATE. SYSTEMIC TPA ATTEMPTED BUT UNSUCCESSFUL. PATIENT DNR/DNI AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101053 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death