BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2160247 · Received July 13, 2011

    Report

    Report Number
    2160247
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    September 27, 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: VISUAL AND AUDIBLE ALARMS DIDN'T MATCHSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: VISUAL AND AUDIBLE ALARMS DIDN'T MATCHOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF INTERNAL 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 22.4 YR