BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1061952 · Received June 16, 2008

    Report

    Report Number
    3006556115-2008-00297
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 18, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED HOWEVER THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT IT IS NOT FUNCTIONING. THE PATIENT'S INTERNAL DEVICE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE. IN ADDITION, THE PATIENT DEVELOPED BELL'S PALSY TWO DAYS AFTER HIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1