BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1172928 · Received September 19, 2008

    Report

    Report Number
    3006556115-2008-00485
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE WILL BE EXPLANTED. THE COMPANY IS IN THE PROCESS OF GATHERING ADDITIONAL INFO. AS SOON AS ADVANCED BIONICS OBTAINS NEW INFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR