BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2012415 · Received March 9, 2011

    Report

    Report Number
    2012415
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 3, 2011
    Report Date
    May 23, 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: PATIENT ACCIDENTALLY DISCONNECTED HIMSELF FROM SYSTEM CONTROLLER FOR APPROXIMATELY 7-8 MINUTESSPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTIONADDITIONAL TEXT: PATIENT ACCIDENTALLY DISCONNECTED HIMSELF FROM SYSTEM CONTROLLER FOR APPROXIMATELY 7-8 MINUTESOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION; PATIENT ERROR IN CARING FOR SYSTEMOTHER CAUSE:INTERVENTION(S): OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : PATIENT RECONNECTED HIMSELF TO SYSTEM CONTROLLERIMPLANT 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 62.7 YR