BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1801504 · Received August 16, 2010

    Report

    Report Number
    1801504
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 15, 2010
    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 FAILURE. ADDITIONAL TEXT: PINS BROKEN IN SYSTEM CONTROLLER CABLES. SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION. ADDITIONAL TEXT: BROKEN PINS IN CABLES. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT ERROR IN CARING FOR SYSTEM. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.

    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 58.5 YR