BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1943050 · Received December 30, 2010

    Report

    Report Number
    1943050
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 4, 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: EXTERNAL CONTROL SYSTEM FAILUREADDITIONAL TEXT: CONTROLLERSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: CONTROLLEROTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLEROTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION.

    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 54.4 YR