BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1935442 · Received November 10, 2010

    Report

    Report Number
    2916596-2010-00290
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 16, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE SYS CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MFR'S LAB AND THE REPORTED EVENT WAS CONFIRMED. THE BLACK AND WHITE POWER CABLES WERE MANEUVERED AND WHILE MOVING THE BLACK POWER CABLE AT THE CONNECTOR END, THE SYS REPORTED A POWER CABLE DISCONNECT ALARM. THE WHITE AND BLACK POWER CABLES WERE THEN INDEPENDENTLY DISCONNECTED AND WHEN THE WHITE POWER CABLE WAS DISCONNECTED THE SYS REPORTED A LOW VOLTAGE ALARM. THE OUTER INSULATION AND THE STRAIN RELIEF OF THE BLACK POWER CABLE AT THE CONNECTOR END WAS REMOVED WHICH REVEALED BROKEN INNER CONDUCTOR WIRES AT THE CONNECTOR END. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTIVE ACTION SYS 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). THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM FROM THE SYS CONTROLLER WHILE AT HOME. THE SYS CONTROLLER WAS IMMEDIATELY EXCHANGED FOR ANOTHER SYS CONTROLLER AND NO FURTHER PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 91740

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other