BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS

    MDR report key: 388009 · Received April 10, 2002

    Report

    Report Number
    6000034-2002-00043
    Event Type
    Malfunction
    Date Received
    April 10, 2002
    Date of Event
    February 5, 2002
    Report Date
    April 10, 2002
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS EXPERIENCED DECREASED PERFORMANCE AND LOSS OF CHANNELS OVER THE LAST SEVERAL YEARS. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY WAS PERFORMED 03/2002. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LTD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR