BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 3041167 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01090
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 10, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS CONFIRMED THAT AN INTERNAL COMPONENT OF THE COMMUNICATOR HAD MELTED DUE TO ELECTRICAL OVERSTRESS. AN EXTERNAL SOURCE WAS NOT MENTIONED. (THERE WAS NO MENTION OF A STORM OR POWER OUTAGE.) 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 'NDT' (FOR NO DIAL TONE) DISPLAYED ON THE PATIENT'S COMMUNICATOR. THE COMMUNICATOR WAS RETURNED TO BSC FOR RELIABILITY ANALYSIS. A REPLACEMENT COMMUNICATOR WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143409 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 0185| N119| 4136