BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 2881511 · Received December 18, 2012

    Report

    Report Number
    3006556115-2012-00591
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO SOUND QUALITY ISSUES, HEADACHES, AND PAIN AT THE IMPLANT SITE. EXTERNAL EQUIPMENT WAS EXCHANGED AND ADDITIONAL TROUBLESHOOTING WAS PERFORMED. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention