BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082094 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00411
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 24, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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, TESTING AT THE CLINIC SHOWED HIGH IMPEDANCE MEASUREMENTS. AN X-RAY DONE (DATE NOT REPORTED) SHOWED AN "INTERRUPTION IN THE ELECTRODE ARRAY". THE DEVICE WAS NOT EVALUATED BY COCHLEAR REP. 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 MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention