BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1013973 · Received March 14, 2008

    Report

    Report Number
    6000034-2008-00109
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 14, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FELL AND HIT HER HEAD IN LATE 2007. THE PT REPORTED THAT SINCE THAT INCIDENT, SHE HAS BEEN UNABLE TO HEAR WITH THE COCHLEAR IMPLANT SYSTEM. AN X-RAY ( DATE NOT REPORTED) SHOWED THE ELECTRODE ARRAY TO BE IN THE COCHLEA. ADJUSTING THE EXTERNAL TRANSMITTING COIL DID NOT SOLVE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 SHOWED THE COCHLEAR IMPLANT WAS NOT FUNCTIONING. REIMPLANTATION SURGERY 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