BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1241008 · Received November 21, 2008

    Report

    Report Number
    6000034-2008-00669
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 30, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT'S DEVICE WAS EXPLANTED IN 2008, DUE TO THE ELECTRODE ARRAY MIGRATING OUT OF THE COCHLEA. AN INFECTION WAS ALSO REPORTED. NO REIMPLANT SURGERY PLANS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(ST) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention