BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1012805 · Received March 12, 2008

    Report

    Report Number
    6000034-2008-00099
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 11, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING- THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST'S REPORT ON JANUARY 30, 2008, THE PT REPORTEDLY HIT HER HEAD (DATE NOT REPORTED) AND THEN WAS UNABLE TO HEAR WITH THE COCHLEAR IMPLANT SYSTEM. EXCHANGING EXTERNALS AND REPROGRAMMING THE SOUND PROCESSOR DID NOT RESOLVE THE PROBLEM. THE RESULT OF AN INTEGRITY TEST THEREAFTER WERE CONSISTENT WITH MALFUNCTION OF THE RECEIVER/STIMULATOR. EXPLANT/REIMPLANT SURGERY IS SCHEDULED.

    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