BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2090831 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00238
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PATIENT'S DEVICE IS UNDER CONSIDERATION.

    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 18 YR Required Intervention