BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1931115 · Received November 10, 2010

    Report

    Report Number
    2916596-2010-00295
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 12, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVALUATION AND THE INTERMITTENT ALARMS WERE CONFIRMED DURING THE ANALYSIS OF THE CONTROLLER. DURING FUNCTIONAL TESTING OF THE CONTROLLER, THE "POWER CABLE DISCONNECT" ALARMS OCCURRED WHEN THE BLACK POWER LEAD WAS MANEUVERED AT THE CONNECTOR END OF THE LEAD. FURTHER EVALUATION OF THE SYSTEM CONTROLLER REVEALED THAT THE BROWN CONDUCTOR IN THE BLACK POWER LEAD WAS BROKEN. THE LOG FILE WAS ALSO REVIEWED AND SUPPORTED THE REPORTED EVENT. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR 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 COORD THAT THE PT EXPERIENCED INTERMITTENT BEEPING WHEN HE MOVED OR WAS LYING STILL IN BED. THIS OCCURRED WHILE HE WAS CONNECTED TO THE POWER MODULE OR ON BATTERIES. A FEW WEEKS PRIOR, THIS ISSUE HAD OCCURRED AND THE PT'S BATTERY CLIPS WERE EXCHANGED AND HIS BATTERIES WERE CLEANED AND INSPECTED. THIS TIME THE VAD COORD EXCHANGED THE SYSTEM CONTROLLER WITHOUT INCIDENT. THE PT REMAINS ONGOING ON THE LVAD AND NO FURTHER ISSUES 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other