BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 699460 · Received October 10, 2005

    Report

    Report Number
    6000034-2005-00294
    Event Type
    Malfunction
    Date Received
    October 10, 2005
    Date of Event
    June 1, 2005
    Report Date
    October 10, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER 3 YEARS OF COCHLEAR IMPLANT USE, THIS PATIENT REPORTEDLY EXPERIENCED INTERMITTENT HARING WITH HER DEVICE. INTEGRITY TEST RESULTS IN 08/2005 SHOWED HIGH IMPEDENCES ON MULTIPLE ELECTRODES. IMAGING CONFIRMED THAT ALL OF THE ELECTRODES WERE INSIDE THE COCHLEAR. DUE TO THIS PATIENT'S DECREASED HEARING PERFORMED AND MULTIPLE ELECTRODE FAULTS, THE DEVICE WILL BE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention