BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1930164 · Received November 22, 2010

    Report

    Report Number
    2916596-2010-00310
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 26, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO TH MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT NOTICED THAT HER POWER LEADS ON HER SYSTEM CONTROLLER WERE GETTING VERY WARM AND THEN NOTICED THAT THE BLACK POWER LEAD STARTED SPARKING. THE PATIENT DESCRIBED IT AS "SMALL FLAMES". RED HEART ALARMS SOUNDED AND THE PATIENT'S SON EXCHANGED THE SYSTEM CONTROLLER. THE PATIENT LOST CONSCIOUSNESS FOR A SHORT PERIOD OF TIME (SECONDS). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND MADE SURE THERE WAS NO DAMAGE TO HER POWER BASE UNIT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY FURTHER ISSUES. THE PATIENT REMAINS ONGOING ON THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 1315 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention