BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1032398 · Received April 17, 2008

    Report

    Report Number
    6000034-2008-00198
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 6, 2007
    Report Date
    April 17, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED IN 2006 THAT SHE WAS NOT HEARING WELL WITH THE COCHLEAR IMPLANT SYSTEM. REPORTEDLY, THE PROBLEM OCCURRED AT THE SAME TIME THAT THE PATIENT HAD MIDDLE EAR INFECTION. THE PATIENT ALSO REPORTED HITTING HER HEAD WHILE GETTING OUT OF A CAR (DATE NOT REPORTED). RESULTS OF AN INTEGRITY TEST DONE IN 2007 SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION WITH TWO ELECTRODES WITH ABNORMAL OUTPUT. THE TWO ELECTRODES WERE DEACTIVATED IN THE PATIENT'S SOUND PROCESSING PROGRAM. THE PATIENT'S AUDITORY PERCEPTION CONTINUED TO DECREASE. A SECOND INTEGRITY TEST WAS DONE ON THREE AND A HALF MONTHS LATER WITH THE SAME RESULTS. THE PATIENT'S DEVICE WAS EXPLANTED THREE MONTHS LATER, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    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) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention