BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1033713 · Received April 25, 2008

    Report

    Report Number
    6000034-2008-00215
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, THE PT NEVER GAINED FULL BENEFIT FROM THE COCHLEAR IMPLANT SYSTEM. REPORTEDLY, THE PT CONSISTENTLY USED HIS IMPLANT SYSTEM 2002 THROUGH 2007, BUT DISCONTINUED USING THE COCHLEAR DEVICE IN 2007 DUE TO POOR SOUND QUALITY. THE PT PRESENTED AT THE CLINIC IN 2008 WITH THE INTENTION OF TRYING TO RESUME IMPLANT USE. REPROGRAMMING OF THE PT'S SOUND PROCESSING PROGRAM DID NOT ALLEVIATE THE PROBLEM. PERSISTENT FACIAL NERVE STIMULATION WAS NOTED. THE PT WAS SCHEDULED FOR EXPLANT/REIMPLANT SURGERY ON 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. CI24R(CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention