BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2040391 · Received February 15, 2011

    Report

    Report Number
    2916596-2011-00094
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 14, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF RED HEART ALARMS WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE EVAL OF THE RETURNED SYSTEM CONTROLLER REVEALED A COMPROMISED INNER CONDUCTOR IN THE POWER LEAD. THE BLACK POWER CABLE WAS FOUND TO HAVE A COMPROMISED BROWN (RSOC-LINE) INNER CONDUCTOR AT THE CONNECTOR END. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'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 MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PT RECEIVED A SERIES OF RED HEART ALARMS AND THE "SELF-TEST" BUTTON ON THE SYSTEM CONTROLLER DID NOT WORK. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 91963

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other