BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1031665 · Received April 18, 2008

    Report

    Report Number
    6000034-2008-00206
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 18, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    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 PRESENTED AT THE CLINIC REPORTING PAIN IN THE IMPLANT AREA. TESTING DONE AT THE CLINIC SHOWED THERE WAS NO RESPONSE ON NEURAL RESPONSE TELEMETRY TESTS AND THE PT COULD NOT HEAR WITH THE COCHLEAR IMPLANT SYSTEM. THE RESULTS OF AN INTEGRITY TEST DONE IN 2008 SHOWED THE NORMAL STIMULATOR/RECEIVER FUNCTION WITH MULTIPLE SHORT CIRCUIT ELECTRODES. REIMPLANTATION IS RECOMMENDED BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.

    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