BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN

    MDR report key: 182097 · Received December 20, 1996

    Report

    Report Number
    1721493-1996-00041
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    November 21, 1996
    Report Date
    December 20, 1996
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CHILD'S PARENTS REPORTED A DECREASE IN THE CHILD'S RESPONSIVENESS. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANTATION/REIMPLANTATION SURGERY WAS DONE ON 12/03/1996. THE SURGEON DETERMINED THAT THE ELECTRODE ARRAY OF THE REPLACEMENT DEVICE WAS KINKED. THE SECOND DEVICE WAS EXPLANTED & A THIRD DEVICE REIMPLANTED ON 12/06/1996. THE SERIAL NUMBER REFERANCE FOR THIS REPORT IS THE FIRST DEVICE.

    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 MCM COCHLEAR LTD CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention