BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION-COCHLEAR IMPLANT

    MDR report key: 1061657 · Received June 8, 2008

    Report

    Report Number
    1061657
    Event Type
    Malfunction
    Date Received
    June 8, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 8, 2008
    Manufacturer
    ADVANCED BIONICS HEADQUARTERS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A RIGHT COCHLEAR IMPLANT PERFORMED USING THE CLARION 1.2 DEVICE EIGHT YEARS AGO. AFTER A SATISFACTORY INITIAL PERFORMANCE, PATIENT SUFFERED A RECENT DEVICE FAILURE AND PRESENTS FOR ELECTIVE REVISION SURGERY.THERE WAS DENSE NEW BONE FORMATION OVER THE MASTOID AND THE FEEDTHROUGH OF THE COCHLEAR IMPLANT ELECTRODE. THE DEVICE ITSELF APPEARED NORMAL UPON EXTRACTION. THERE WAS A SLIGHT RECURRENCE OF SLOW OUTFLOW OF CEREBROSPINAL FLUID FROM THE COCHLEOSTOMY AFTER THE IMPLANT ELECTRODE WAS EXTRACTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR