BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2180933 · Received July 7, 2011

    Report

    Report Number
    2916596-2011-00278
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 7, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED RED HEART ALARMS WERE CONFIRMED DURING ANALYSIS. DURING FUNCTIONAL TESTING, MOVEMENT OF THE BLACK POWER LEAD AT THE CONNECTOR END RESULTED IN LOW VOLTAGE, RED HEART AND YELLOW BATTERY ALARMS WHILE CONNECTED TO A POWER MODULE. UPON FURTHER EVAL, THE BLACK POWER LEAD WAS FOUND TO HAVE A COMPROMISED BROWN CONDUCTOR (BATTERY FUEL GAUGE LINE) AT THE CONNECTOR END. 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 CUSTOMER. 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 COORDINATOR THAT THE PT EXPERIENCED INTERMITTENT RED HEART ALARMS. THE PT HAD A CLAM SHELL REPAIR ON HIS DRIVELINE; HOWEVER, IT DID NOT RESOLVE THE ALARMS. THE SYSTEM CONTROLLER WAS THEN EXCHANGED AND THE ALARMS WERE RESOLVED. THE PT REMAINS ONGOING.

    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 61 YR Other