BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 113149 · Received August 14, 1997

    Report

    Report Number
    6000034-1997-00087
    Event Type
    Malfunction
    Date Received
    August 14, 1997
    Date of Event
    September 9, 1996
    Report Date
    August 14, 1997
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS DEVICE MALFUNCTION WAS 09/09/96. THE INFO WAS INADVERTENTLY NOT FORWARDED TO COCHLEAR CORP BY COCHLEAR'S EUROPEAN OFFICE FOR MDR FILING. AN EMAIL REGARDING THE NECESSITY FOR TIMELY REPORTING HAS BEEN SENT TO THE APPROPRIATE EMPLOYEES.

    Description of Event or Problem · 1

    THE PATIENT REPORTED NO LONGER HEARING ON SEVERAL ELECTRODES. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY WAS DONE ON 01/08/1997.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention