BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1914604 · Received December 3, 2010

    Report

    Report Number
    1914604
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 15, 2010
    Report Date
    April 22, 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

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMPADDITIONAL TEXT: HIGH INFLOW VELOCITY WITH CANNULA POINTING TOWARD SEPTUM, NEED TO REORIENTSPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITIONADDITIONAL TEXT: INFLOW CANNULA POINTED TOWARD SEPTUM, REORIENTATION PROCEDUREOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : (B)(4) 2010 LVAD DEVICE REVISION OF INFLOW CANNULA LOCATIONIMPLANT 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 59 YR