BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2153603 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07427
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 7, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS COMMUNICATOR AND POWER CORD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LATITUDE COMMUNICATOR WAS BEING RETURNED DUE MELTING OF THE COMMUNICATOR AND THE POWER CORD. THERE WERE NO INJURIES REPORTED AS A RESULT OF THE MELTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT INDICATED THEY WOULD BE RETURNED THE COMMUNICATOR.

    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 64 YR 5076| 6947| 4555| N119