BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1221925 · Received November 4, 2008

    Report

    Report Number
    6000034-2008-00627
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED, NOVEMBER 04, 2008. LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED SUDDEN ONSET OF PAIN AND DECREASING LOUDNESS WHEN USING THE COCHLEAR IMPLANT SYSTEM. THERE WAS NO TRAUMA REPORTED PRIOR TO THE SUDDEN PAIN. RESULTS OF A CT SCAN WERE NOT REPORTED. RESULTS OF AN INTEGRITY TEST DONE IN 2008, SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION. REPORTEDLY, DUE TO THE PAIN, THE PATIENT HAS NOT WORN THE DEVICE SINCE THE END OF 2008. THE PATIENT'S DEVICE WAS EXPLANTED THE FOLLOWING MONTH, 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 MCM COCHLEAR LTD. CI24R(CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention