BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1853486 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14812
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 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 SUPPLY DISPLAYED SIGNS OF MELTING ALONG THE TOP EDGE NEAR THE STRAIN RELIEF AND AN AUDIBLE RINGING COULD BE HEARD DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT STATED THE POWER SUPPLY WAS HOT WITH A BURNING SMELL AND AN 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 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)| N119| 6948| 4193| 4592