BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3963506 · Received June 18, 2014

    Report

    Report Number
    3006556115-2014-00293
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ADVANCED BIONICS WAS MADE AWARE THAT THE PT SUFFERED A HEAD TRAUMA. AFTER THE TRAUMA THE PT EXPERIENCED PAIN AND SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND PROGRAMMING ADJUSTMENTS HAVE BEEN MADE, HOWEVER, THE ISSUE IS NOT RESOLVED. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358471 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR