BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1070908 · Received July 3, 2008

    Report

    Report Number
    6000034-2008-00373
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 9, 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 TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2006, THE PT REPORTED "FEELING UNCOMFORTABLE" WHEN USING THE COCHLEAR IMPLANT SYSTEM. RESULTS OF AN INTEGRITY TEST DONE ON THE SAME MONTH, SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION, BUT THE TESTING COULD NOT BE COMPLETED, DUE TO PAIN AT LOW STIMULATION LEVELS. THE SURGEON CLASSIFIED THE PT'S COMPLAINT AS PSYCHOLOGICAL. THE PT RESUMED DEVICE USE IN MAY 2006. ON THE MONTH PRIOR, THE PT AGAIN REPORTED PAIN AND VERTIGO WHILE USING THE DEVICE AND STOPPED USING THE SOUND PROCESSOR. A REPEAT INTEGRITY TEST DONE ON TWO DAYS LATER, CONFIRMED THE RESULTS OF THE FIRST TEST. AN X-RAY WAS RECOMMENDED TO VERIFY CORRECT DEVICE PLACEMENT. THE PT'S DEVICE WAS EXPLANTED 2008 ( DATE NOT REPORTED) 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 COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention