BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE

    MDR report key: 2992239 · Received March 7, 2013

    Report

    Report Number
    2992239
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 17, 2007
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    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, DRIVE UNIT FAILURE.SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96841 HEARTMATE XVE LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1