BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2001917 · Received February 27, 2011

    Report

    Report Number
    2001917
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    December 21, 2010
    Report Date
    May 6, 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 FAILURESPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILUREADDITIONAL TEXT: SYSTEM CONTROLLERSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: PT HAD RED HEART ALARM AND MSG TO CHANGE CONTROLLEROTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTIONOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLEROTHER INTERVENTION :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 53.7 YR