BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1243097 · Received November 21, 2008

    Report

    Report Number
    6000034-2008-00674
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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, AFTER WAKING UP ONE MORNING, THE PATIENT REPORTED "POPPING", "STATIC" AND THEN "LITTLE TO NO SOUND" WHEN USING THE COCHLEAR IMPLANT SYSTEM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 SHOWED THE IMPLANT WAS NOT FUNCTIONING. THE PATIENT'S DEVICE WAS EXPLANTED SIX DAYS LATER, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention