BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1950278 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22334
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 4, 2010
    Report Date
    November 15, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET QUALITY ASSURANCE LAB HAS CONFIRMED THE ALLEGATION. THE POWER SUPPLY WAS CONFIRMED TO BE EXCESSIVELY HOT TO THE TOUCH, MELTING TO THE POWER SUPPLY WAS OBSERVED AND DISPLAYED AN AUDIBLE RINGING COULD BE HEARD DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT OBSERVED A YELLOW LIGHT FLASH ON THE COMMUNICATOR. WHEN THE PATIENT PRESSES THE BUTTON NOTHING APPEARS ON THE SCREEN. THE SCREEN REMAINS BLANK WITH NO TEXT. THE ACTION BUTTON IS WHITE AND THE GREEN LIGHT IS FLASHING. NO ADVERSE PATIENT EFFECTS REPORTED. NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 0174| H175| 4469| 4517| N118