BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1021830 · Received March 27, 2008

    Report

    Report Number
    6000034-2008-00141
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 PATIENT HEARD A "CRACKLING" AND THEN HAD NO SOUND WITH THE COCHLEAR IMPLANT SYSTEM. TESTING AT THE CLINIC OF THE SOUND PROCESSING EQUIPMENT SHOWED THEY WERE FUNCTIONING PROPERLY. RESULTS OF AN INTEGRITY TESTS DONE IN 2008 SHOWED THE COCHLEAR IMPLANT SYSTEM WAS NOT FUNCTIONING. REIMPLANTATION IS PLANNED, BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention