BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1013974 · Received March 14, 2008

    Report

    Report Number
    6000034-2008-00110
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 ELECTRODE ARRAY COULD NOT BE FULLY INSERTED INTO THE COCHLEA DUE TO FIBROUS TISSUE INSIDE THE COCHLEA, RESULTING IN MIGRATION OF THE ELECTRODE ARRAY OUT OF THE COCHLEA. THE PT'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 22 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention