BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1062683 · Received June 11, 2008

    Report

    Report Number
    6000034-2008-00315
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    December 5, 2008
    Report Date
    June 11, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, REPORTEDLY, THE PT IS SENSITIVE TO THE TOUCH AROUND THE RECEIVER/STIMULATOR AREA AND DOES NOT SHOW MUCH AUDITORY RESPONSES. EXCHANGING EXTERNALS DID NOT HELP THE PROBLEM. RESULTS OF A CT SCAN WERE INCONCLUSIVE. RESULTS OF AN INTEGRITY TEST DONE IN 2008 SHOWED NO CONNECTION WITH THE IMPLANT. DUE TO THE RECEIVER/STIMULATOR AREA BEING SENSITIVE, SOME TYPE OF TRAUMA MAY HAVE DISPLACED THE INTERNAL MAGNET FROM THE MAGNET POCKET. A X-RAY OF THE SITE WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(ST) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention