BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1760300 · Received July 16, 2010

    Report

    Report Number
    6000034-2010-00457
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 24, 2010
    Report Date
    February 10, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6, 2010. THIS REPORT IS FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED DIZZINESS AND HEADACHES DURING AN AIRLINE FLIGHT IN (B)(6), 2010. IT WAS FURTHER REPORTED THAT SHE EXPERIENCED A SHOCKING SENASATION AND A METALLIC TASTE IN HER MOUTH SUBSEQUENT TO THE AIRLINE FLIGHT. SHE REPORTS NOT HAVING WORN HER SPEECH PROCESSOR IN OVER 6 YEARS. HER LAST MAPPING APPOINTMENT WAS IN 2001.EXPLANT IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2010. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention