BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1960310 · Received December 15, 2010

    Report

    Report Number
    2916596-2010-00341
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 15, 2010
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MANUFACTURER'S LAB AND THE EVENT OF THE SYSTEM CONTROLLER ALARMING WAS CONFIRMED. MOVEMENT OF THE WHITE POWER CABLE AT THE CONNECTOR END RESULTED IN LOW BATTERY ALARMS WHILE TETHERED TO THE TEST POWER MODULE. THE WHITE POWER CABLE WAS STRIPPED AT THE CONNECTOR END REVEALING A BROKEN INNER CONDUCTOR. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/1001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THE PT'S SYSTEM CONTROLLER WAS INTERMITTENTLY BEEPING, BUT THE LED LIGHTS WERE NOT ILLUMINATING. THE SYSTEM CONTROLLER WAS SWAPPED OUT FOR ANOTHER SYSTEM CONTROLLER AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP 103696 84427

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other