BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1851944 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14580
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 8, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMUNICATOR ALONG WITH THE POWER SUPPLY WERE RETURNED FOR ANALYSIS. POST MARKET QUALITY ASSURANCE FOUND THAT THE RETURNED POWER BRICK GOT HOT TO THE TOUCH. ANALYSIS ALSO CONFIRMED THAT THE PLASTIC HOUSING WAS DEFORMED, AND HAD A BURNING SMELL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT THAT THE COMMUNICATOR HAD SCREEN FAILURE AFTER A RECENT STORM. A REPLACEMENT COMMUNICATOR WAS SHIPPED TO THE PATIENT.

    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 75 YR 4542| H217| 4086| 0158