BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1945081 · Received January 3, 2011

    Report

    Report Number
    1945081
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 11, 2010
    Report Date
    May 4, 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.SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. ADDITIONAL TEXT: BREAK IN PERC LEAD CAUSING PUMP TO STOP. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION. ADDITIONAL TEXT: WIRES BROKEN AT THE INSERTION SITE OF PERC LEAD TO THE PUMP. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): REPLACEMENT OF PUMP. 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 37.4 YR