BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC IVAD

    MDR report key: 2031441 · Received March 28, 2011

    Report

    Report Number
    2031441
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    August 5, 2010
    Report Date
    June 3, 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 THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSISADDITIONAL TEXT: THROMBUS FORMATION DUE TO VADSPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFYADDITIONAL TEXT:OTHER COMPONENT: THE OVERALL DEVICE WAS WEAK; THERE WASN'T MALFUNCTION OF A SPECIFIC PART.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : FULL ANTICOAGULATION THAT HAD TO BE MINIMIZED WITH HEMORRHAGIC STROKES; VAD IN FIXED MODE, SET RATE.IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC IVAD LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19.8 YR Death