BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1050259 · Received May 22, 2008

    Report

    Report Number
    6000034-2008-00269
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    February 28, 2008
    Report Date
    May 22, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE SURGEON WAS NOT ABLE TO GET A FULL INSERTION OF THE ELECTRODE ARRAY INTO THE PATIENT'S COCHLEA DUE TO OSSIFICATION. THE PATIENT DECIDED TO HAVE THE DEVICE EXPLANTED ONE WEEK AFTER THE INITIAL SURGERY. REIMPLANTATION IS PLANNED FOR 2008 (DATE NOT REPORTED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention