BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3111821 · Received May 7, 2013

    Report

    Report Number
    2916596-2013-00563
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER AND THE PT CABLE WERE REPLACED. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED SHE OBSERVED LOW SPEED, LOW FLOW, AND PUMP OFF ALARMS ON PT HISTORY SCREEN. VAD COORDINATOR OBSERVED DAMAGE TO WHITE LEAD OF SYSTEM CONTROLLER, GRAY WIRE JACKET TORN. SHE ALSO REPORTED DRAINAGE AT DRIVELINE EXIT SITE. LOG FILES SUBMITTED FOR ANALYSIS. LOG FILE RECORDED 2 MOTOR STOP EVENTS AND APPROXIMATELY 5 LOW SPEED HAZARD EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199875 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 100601

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention