BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1233904 · Received November 13, 2008

    Report

    Report Number
    6000034-2008-00656
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    November 13, 2008
    Report Date
    October 30, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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, IN 2008 THE PATIENT PRESENTED WITH AN EAR INFECTION. THE SURGEON ASPIRATED THE SITE. REPORTEDLY, THERE WAS A CYST BEHIND THE EAR AND INFLAMMATION AROUND THE TRANSMITTING COIL. THE PATIENT WAS STARTED ON IV ANTIBIOTICS AND DISCONTINUED USE OF THE DEVICE. THE PATIENT'S DEVICE WAS EXPLANTED AT ABOUT TEN DAYS LATER. REIMPLANTATION IS PLANNED AFTER THE INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention