BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2022661 · Received March 17, 2011

    Report

    Report Number
    2022661
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    August 21, 2010
    Report Date
    May 13, 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 PUMPSPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION, OUTFLOW GRAFTMALFUNCTION/MALPOSITION, PUMP DRIVE UNIT MALFUNCTION

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMPADDITIONAL TEXT: SUSPECTED THROMBUS OR INFECTIONSPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION; OUTFLOW GRAFT MALFUNCTION/MALPOSITION; PUMP DRIVE UNIT MALFUNCTIONADDITIONAL TEXT: SOFT DEPOSITION WITH LITTLE STRUCTURE THAT WAS YELLOW IN COLOR THROUGHOUT THE PUMP; SOFT DEPOSITION WITH LITTLE STRUCTURE THAT WAS YELLOW IN COLOR THROUGHOUT THE PUMP; SOFT DEPOSITION WITH LITTLE STRUCTURE THAT WAS YELLOW IN COLOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : PATIENT PUT ON ARGATROBAN DUE TO BEING HIT POSITIVE.IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    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 51.4 YR Death