BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1062643 · Received June 11, 2008

    Report

    Report Number
    6000034-2008-00310
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    January 21, 2008
    Report Date
    June 11, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESS IN THE DEVICE LABELING. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED A DECREASE IN HEARING PERFORMANCE OVER TIME WHEN USING THE COCHLEAR IMPLANT SYSTEM. RESULTS OF AN INTEGRITY TEST DONE IN 2007, SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER COMMENTING THIS WAS AN "ELECTIVE" EXPLANT. AS A DEVICE FAULT WAS FOUND DURING THE ROUTINE DEVICE ANALYSIS PROCESS, THIS EVENT IS BEING REPORTED.

    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