BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1821893 · Received August 31, 2010

    Report

    Report Number
    1821893
    Event Type
    Death
    Date Received
    August 31, 2010
    Date of Event
    May 9, 2010
    Report Date
    October 12, 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;PUMP THROMBUS.SPECIFIC COMPONENT(S) INVOLVED: DIC AND HEPARIN INDUCED THROMBOCYTOPENIA.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.INTERVENTION(S): NONE.IMPLANT DEVICE TYPE: LVAD.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS.

    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 56.6 YR Death