BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1131947 · Received August 22, 2008

    Report

    Report Number
    6000034-2008-00478
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2007
    Report Date
    July 29, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED ON AUGUST 22, 2008.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT APPEARS TO BE DERIVING LITTLE BENEFIT FROM THE COCHLEAR IMPLANT SYSTEM. REPORTEDLY, IT IS KNOWN THAT THE ELECTRODE ARRAY HAS MIGRATED FROM THE INITIAL PLACEMENT AND THE BALL ELECTRODE HAS BEEN FLAGGED AS BEING PROBLEMATIC. THE RESULTS OF AN INTEGRITY TESTS DONE IN 2007, WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION. SOUND PROCESSOR PROGRAMMING AND COUNSELING WERE PROVIDED. THE PT'S PERFORMANCE REPORTEDLY DID NOT IMPROVE SIGNIFICANTLY. A REPEAT INTEGRITY TEST WAS DONE THE FOLLOWING YEAR. AT THE TIME OF THE TEST, THE PT'S EXTERNAL MICROPHONE WAS FOUND TO BE MALFUNCTIONING. THE RESULTS OF THE INTEGRITY TEST, DONE WITH WORKING EXTERNAL EQUIPMENT, WERE UNCLEAR. THE PT , HOWEVER, WAS CLEARLY RESPONDING TO SOUND. MONITORING OF THE PT'S PROGRESS WAS RECOMMENDED. THE SURGEON CONSIDERED THE TREATMENT ALTERNATIVES TWO MONTHS LATER, REPORTED THAT THE PT'S DEVICE WOULD BE EXPLANTED AND THE PT WOULD BE REIMPLANTED WITH A NEW DEVICE IN 2008

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention