BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2243132 · Received September 11, 2011

    Report

    Report Number
    2243132
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    August 24, 2011
    Report Date
    April 19, 2012
    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. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. ADDITIONAL TEXT: PUMP MALFUNCTION. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION. ADDITIONAL TEXT: PUMP MALFUNCTION. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): REPLACEMENT OF PUMP. IMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT). MALFUNCTION DEVICE TYPE: LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60.1 YR LEVITRONIX CENTRIMAG - RVAD| LEVITRONIX CENTRIMAG - RVAD