BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1771257 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12372
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 7, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMUNICATOR WAS RETURNED FOR ANALYSIS. THE POST MARKET QUALITY ASSURANCE LABORATORY CONFIRMED THE REPORTED ALLEGATION. THE COMMUNICATOR FAILED TO POWER UP WITH THE RETURNED POWER CORD. THE POWER CORD DID NOT BECOME HOT TO THE TOUCH DURING ANALYSIS, HOWEVER, THE CASE ON THE POWER CORD WAS OBSERVED TO BE MELTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD FOR THE COMMUNICATOR BECAME HOT TO THE TOUCH. NO PATIENT INJURY WAS REPORTED. 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 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 6024| E102| 0125| 1860| 1821