BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2180321 · Received July 27, 2011

    Report

    Report Number
    2180321
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    October 5, 2011
    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: BLOOD PUMP; DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP; DEVICE THROMBOSIS. ADDITIONAL TEXT: BLOOD PUMP CEASED FUNCTIONING ON ITS OWN; HIGH POWERS SEEN SO DEVICE THROMBOSIS SUSPECTED. SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY. ADDITIONAL TEXT: OTHER COMPONENT: SUSPECTED PUMP CLOT. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): NONE. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.

    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 64.2 YR Death