BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1060899 · Received June 13, 2008

    Report

    Report Number
    6000034-2008-00326
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 3, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 PT REPORTED PAIN WHILE USING THE COCHLEAR IMPLANT SYSTEM AND BEGAN REFUSING TO WEAR IT. REPORTEDLY, THE SURGEON IS NOT CLEAR IF THE PAIN IS AN "ADOLESCENT REFUSAL ISSUE" OR "TRUE" PAIN. THE DECISION WAS MADE TO EXPLANT THE DEVICE. THERE ARE NO REIMPLANTATION PLANS.

    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