BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1060903 · Received June 13, 2008

    Report

    Report Number
    6000034-2008-00323
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 6, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PATIENT'S DEVICE WAS EXPLANTED IN '08 DURING SURGERY TO REMOVE A CHOLESTEATOMA. THE PT HAS AN IMPLANT IN THE CONTRALATERAL EAR. THERE WERE NO REIMPLANTATION PLANS REPORTED AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention