BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1070910 · Received July 3, 2008

    Report

    Report Number
    6000034-2008-00371
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 6, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A FINAL. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT REPORTED NON-AUDITORY STIMULATION ( DOUBLE VISION, TONGUE AND JAW STIMULATION), BUT NO AUDITORY STIMULATION WHEN THE COCHLEAR IMPLANT SYSTEM WAS ACTIVATED. AN X-RAY SHOWED THE ELECTRODE ARRAY WAS NOT IN THE COCHLEA. THE PT'S DEVICE WAS EXPLANTED IN 2008, 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. C124RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention