BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2910603 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15365
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    September 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS COMMUNICATOR WAS RETURNED TO BOSTON SCIENTIFIC BECAUSE IT WAS DAMAGED DURING A STORM. ONCE RECEIVED IT WAS NOTED THAT THERE WERE SOME DAMAGED AND MELTED CIRCUITRY AS WELL AS EVIDENCE OF NO DIAL TONE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17464 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR N119| 0185| 4543| 4136