BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2112047 · Received June 2, 2011

    Report

    Report Number
    2112047
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 24, 2011
    Report Date
    September 21, 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: LOW FLOW, RED HEART ALARMSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: CONTROLLER CELL LOWOTHER 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 FAILURESPECIFIC COMPONENT(S) INVOLVED: EXTERMAL 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 18.9 YR