BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1241007 · Received November 21, 2008

    Report

    Report Number
    6000034-2008-00670
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 29, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 PATIENT'S ELECTRODE ARRAY HAD NOT BEEN PLACED CORRECTLY INTO THE COCHLEA DURING THE INITIAL SURGERY. AN X-RAY DONE (DATE NOT REPORTED) DETERMINED THAT THE ELECTRODE ARRAY HAD MIGRATED OUT OF THE COCHLEA. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    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