BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN

    MDR report key: 376389 · Received February 8, 2002

    Report

    Report Number
    6000034-2002-00027
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Date of Event
    May 15, 2000
    Report Date
    February 8, 2002
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S PERFORMANCE HAS DECLINED SINCE 5/2000. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANTATION/REIMPLANTATION SURGERY WAS PERFORMED IN 2002. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LTD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR