BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 239224 · Received September 10, 1999

    Report

    Report Number
    6000034-1999-00109
    Event Type
    Injury
    Date Received
    September 10, 1999
    Date of Event
    June 24, 1999
    Report Date
    September 9, 1999
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS DETERMINED VIA OTOSCOPIC EXAMINATION BY THE AUDIOLOGIST THAT THE ELECTRODE ARRAY OF THE PT'S IMPLANT HAD MIGRATED OUT OF THE COCHLEA AND IS IN THE EAR CANAL. THE CHILD MISSED ONE OR MORE APPOINTMENTS WITH THE OTOLOGIST. THE PT WAS SEEN BY THE OTOLOGIST ON 09/01/1999 AND HAS BEEN SCHEDULED FOR EXPLANT SURGERY ON 09/23/1999. REIMPLANTATION WITH A NEW IMPLANT IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM Implant 24 CHANNEL COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention