BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1031691 · Received April 18, 2008

    Report

    Report Number
    6000034-2008-00211
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    December 15, 2007
    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
    AS
    Reporter Occupation
    OTHER

    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 REPORTED THE COCHLEAR IMPLANT SYSTEM SUDDENLY STOPPED WORKING AND HE COULD NOT HEAR. REPORTEDLY, THERE WERE NO ADVERSE EVENTS OR PROBLEMS AT THIS TIME. IMPLANT TESTS DONE AT THE CLINIC SHOWED THE IMPLANT WAS NOT WORKING. AN X-RAY DONE (DATE NOT REPORTED) SHOWED THE IMPLANT WAS CORRECTLY PLACED IN THE COCHLEA. EXCHANGING THE EXTERNAL EQUIPMENT DID NOT ALLEVIATE THE PROBLEM. THE PT'S DEVICE WAS EXPLANTED IN 2008, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention