BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2024316 · Received March 18, 2011

    Report

    Report Number
    2024316
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    February 14, 2011
    Report Date
    June 1, 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: DEVICE THROMBOSIS. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION; OTHER COMPONENT MALFUNCTION, SPECIFY.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION; OTHER COMPONENT MALFUNCTION, SPECIFY

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS. ADDITIONAL TEXT: PUMP HEMOLYSIS. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION; OTHER COMPONENT MALFUNCTION, SPECIFY. ADDITIONAL TEXT: UNK. OTHER COMPONENT: PUMP SPECIFIC PART STILL UNKNOWN. 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 54.3 YR Death