BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1031209 · Received April 17, 2008

    Report

    Report Number
    6000034-2008-00201
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 17, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING - THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT REPORTED FACIAL NERVE STIMULATION WHILE USING THE COCHLEAR IMPLANT SYSTEM. THE PT'S MOST COMFORTABLE LEVELS WERE REDUCED IN THE SOUND PROCESSOR PROGRAM TO ALLEVIATE THE FACIAL NERVE STIMULATION. SINCE THAT ADJUSTMENT, THE PT'S FAMILY REPORTS THEY HAD GREATER DIFFICULTY COMMUNICATING WITH THE PT. RESULTS FROM AN INTEGRITY TEST DONE IN 2008 SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION WITH MULTIPLE ELECTRODE ANOMALIES. RESULTS OF AN X-RAY TO CONFIRM ELECTRODE PLACEMENT HAD NOT BEEN COMMUNICATED AT THE TIME OF THIS REPORT.

    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