BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1880081 · Received October 22, 2010

    Report

    Report Number
    2124215-2010-20580
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 30, 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 CONFIRMED THE ALLEGATIONS OF NO POWER TO THE COMMUNICATOR AND THE POWER BRICK BEING EXCESSIVELY HOT. DURING ANALYSIS THERE WAS AN AUDIBLE RINGING THAT COULD BE HEARD FROM THE POWER BRICK.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT THE COMMUNICATOR HAD NO POWER AND WAS HOT TO THE TOUCH. NO ADVERSE PATIENT EFFECTS OR INJURIES WERE REPORTED. THE COMMUNICATOR WILL BE RETURNED FOR ANALYSIS.

    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 77 YR E110| 4469| 0184