BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1241006 · Received November 21, 2008

    Report

    Report Number
    6000034-2008-00672
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 24, 2008
    Report Date
    November 2, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, IN 2008, THE PATIENT REPORTED NO SOUND AND FACIAL NERVE STIMULATION WHEN USING THE COCHLEAR IMPLANT SYSTEM. PATIENT REPORTED FALLING IN 2007, BUT DID NOT HIT HER HEAD. EXCHANGING THE EXTERNAL EQUIPMENT DID NOT SOLVE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 SHOWED NORMAL RECEIVER/STIMULATOR AND ELECTRODE ARRAY FUNCTION. A CT SCAN DONE IN 2007 WAS "WITHIN NORMAL LIMITS". REPROGRAMMING THE PATIENT'S SOUND PROCESSOR PROGRAM AND A MEDICAL EVALUATION WAS RECOMMENDED. THE PATIENT'S DEVICE WAS EXPLANTED ON APPROX TWO MONTHS AFTER THE ORIGINAL MONTH, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY. THE PATIENT WAS ALSO IMPLANTED IN THE CONTRALATERAL EAR DURING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24R(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention