BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN

    MDR report key: 245461 · Received October 19, 1999

    Report

    Report Number
    6000034-1999-00129
    Event Type
    Malfunction
    Date Received
    October 19, 1999
    Date of Event
    January 1, 1999
    Report Date
    October 19, 1999
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED NO LONGER HEARING SOUND SENSATIONS. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONINGACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY WAS DONE ON 10/01/1999. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LIMITED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR