BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1884959 · Received October 28, 2010

    Report

    Report Number
    2124215-2010-20992
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 30, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMUNICATOR WAS RETURNED FOR ANALYSIS. THE POST MARKET QUALITY ASSURANCE LAB CONFIRMED THE REPORTED ALLEGATION. THE POWER CORD BECAME HOT TO THE TOUCH AND THE AUDIBLE SOUNDS WAS HEARD DURING TESTING. IN ADDITION THERE WAS EVIDENCE OF THE CASE BEING DEFORMED BEFORE THE ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WOULD NOT POWER ON AND THE POWER SUPPLY HAD BECOME HOT TO THE TOUCH WITH A HIGH PITCHED AUDIBLE SOUND COMING FROM IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6482

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4555| 4086| 0184| H217