BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2211969 · Received August 10, 2011

    Report

    Report Number
    2916596-2011-00349
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT WHEN THE PT WAS SWITCHED TO THEIR BACKUP SYSTEM CONTROLLER, IT FAILED TO START THE PUMP. THE SYSTEM CONTROLLER WAS EXCHANGED BACK TO THE PRIMARY SYSTEM CONTROLLER AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 103431

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention