BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 698983 · Received April 12, 2006

    Report

    Report Number
    6000034-2006-00129
    Event Type
    Injury
    Date Received
    April 12, 2006
    Date of Event
    September 1, 2005
    Report Date
    April 12, 2006
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST REPORT, THIS PATIENT EXPERIENCED AN IRRITATION ASSOCIATED WITH HIS SPEECH PROCESSOR RUBBING AGAINST THE SKIN BEHIND THE PINNA IN SEPTEMBER 2005. ON MARCH 13, HE RETURNED TO THE IMPLANT CENTER, AT THAT TIME, THE IMJPLANT WAS EXPOSED. HIS SURGEON WILL REVISE THE SKIN FLAP ON APRIL 13, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(CS) *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention