BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1659111 · Received April 14, 2010

    Report

    Report Number
    1659111
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    June 8, 2009
    Report Date
    May 19, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS;SPECIFIC COMPONENT(S) INVOLVED: INFLOW VALVE, OUTFLOW VALVE.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS; NO FLOW IN INFLOW CANNULA ON ECHO. SPECIFIC COMPONENT(S) INVOLVED: INFLOW VALVE; OUTFLOW VALVE; REDUCED FLOW ON ECHO; REDUCED FLOW ON ECHO. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): INTRAVENOUS ARGATROBAN THERAPY. IMPLANT DEVICE TYPE: LVAD; MALFUNCTION DEVICE TYPE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55.2 YR Death