BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 1083059 · Received February 19, 2008

    Report

    Report Number
    3006556115-2008-00050
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A LOSS OF SOUND. TESTING PERFORMED BY THE CENTER CONFIRMED THE DEVICE WAS NOT FUNCTIONING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC N/I

    Patients

    Seq Age Sex Outcome Treatment
    1