BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 713050 · Received November 22, 2005

    Report

    Report Number
    6000034-2005-00337
    Event Type
    Malfunction
    Date Received
    November 22, 2005
    Date of Event
    August 24, 2004
    Report Date
    November 22, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN SEPTEMBER 2004, THE PT WAS IN AN AUTOMOBILE ACCIDENT. FOLLOWING THE ACCIDENT, SHE REPORTED PAIN AND DECREASED SOUND. QUALITY. AN INTEGRITY TEST SHOWED UNSUAL RESULTS ON 3 ELECTRODES. A SPEECH PROCESSOR PROGRAM WITH THESE ELECTRODES DELATED RESOLVED THE COMPLAINT OF PAIN. A SECOND INTEGRITY TEST WAS DONE 08/2005. IT WAS DETERMINED THAT MULTIPLE ELECTRODES WERE NOT FUNCTIONING APPROPRIATELY

    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 25 YR Required Intervention