BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1060018 · Received June 12, 2008

    Report

    Report Number
    3006556115-2008-00320
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 3, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING EPISODES OF FACIAL NERVE STIMULATION. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT THE DEVICE WAS FUNCTIONAL. THE PT'S INTERNAL DEVICE WAS EXPLANTED. THAT PT WAS IMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    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