BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1013975 · Received March 14, 2008

    Report

    Report Number
    6000034-2008-00111
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 14, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, ELECTRODE TESTING SHOWED THAT AN INCREASING NUMBER OF ELECTRODES BECAME OPEN CIRCUIT OVERTIME. INITIALLY THE PT DID NOT NOTICE ANY PERFORMANCE OR SOUND QUALITY CHANGES. IN 2008, THE PT REPORTED POOR SOUND QUALITY AND LOUDNESS WITH THE COCHLEAR IMPLANT SYSTEM. MULTIPLE OPEN CIRCUIT ELECTRODES WERE FOUND DURING CLINIC TESTING. THE OPEN CIRCUIT ELECTRODES WERE DEACTIVATED IN THE SOUND PROCESSING PROGRAM, BUT DID NOT SOLVE THE PROBLEM. ON THE NEXT DAY, THE PT'S WIFE CALLED TO REPORT THE PT COULD NO LONGER HEAR WITH THE COCHLEAR DEVICE. RESULTS OF AN INTEGRITY TEST DONE ON THREE DAYS LATER, WERE CONSISTENT WITH NORMAL RECEIVER STIMULATOR FUNCTION WITH MULTIPLE OPEN CIRCUIT ELECTRODES. EXPLANT/REIMPLANTATION SURGERY IS SCHEDULED FOR THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. C124RE (CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention