BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1081758 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00415
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 26, 2008
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 STATIC WHEN USING THE COCHLEAR IMPLANT SYS. THERE WAS NOT TESTING BY COCHLEAR STAFF PRIOR TO EXPLANTATION. THE PT WAS EXPLANTED IN 2008, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY. THE PT REPORTEDLY EXPERIENCED THE SAME PROBLEMS WITH THE NEW DEVICE.

    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