BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1062293 · Received June 17, 2008

    Report

    Report Number
    6000034-2008-00334
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    February 28, 2008
    Report Date
    June 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
    TX, 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, RESULTS OF AN INTEGRITY TEST DONE IN 2008 WAS CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH MULTIPLE OPEN AND SHORT CIRCUIT ELECTRODES. DEACTIVATION OF THE OPEN AND SHORT CIRCUIT ELECTRODES DID NOT SOLVE THE PROBLEM. REPORTEDLY THE PT HAS MONDINI SYNDROME, AN ENLARGED VESTIBULAR AQUEDUCT AND A HISTORY OF RECURRENT OTTIS MEDIA. AN X-RAY SHOWED "NORMAL" PLACEMENT OF THE ELECTRODE ARRAY. EXPLANTATION/REIMPLANTATION IS SCHEDULED FOR FOUR MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO Required Intervention