BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1173453 · Received September 23, 2008

    Report

    Report Number
    6000034-2008-00549
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT REPORTED HEADACHES SHE ATTRIBUTED TO THE PRESENCE OF THE IMPLANT. REPORTEDLY, THE PT HAD NOT USED THE DEVICE FOR TEN YEARS DUE TO POOR PERFORMANCE. THE PT'S DEVICE WAS EXPLANTED IN 20088, SO THAT AN MRI COULD BE DONE. THE PT IS NOT PLANNING TO BE REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention