BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1213519 · Received October 27, 2008

    Report

    Report Number
    6000034-2008-00599
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 29, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    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, THE PATIENT'S FATHER REPORTED THAT THE PATIENT'S PERFORMANCE WAS NOT AS GOOD AS EXPECTED WHEN USING THE COCHLEAR IMPLANT SYSTEM. IT WAS ALSO REPORTED THAT THE ELECTRODE ARRAY WAS EITHER PARTIALLY INSERTED OR HAD EXTRUDED FROM THE COCHLEA. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008 (DATE NOT REPORTED). A NEW COCHLEAR IMPLANT WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention