BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 610584 · Received July 13, 2004

    Report

    Report Number
    6000034-2004-00194
    Event Type
    Malfunction
    Date Received
    July 13, 2004
    Date of Event
    July 9, 2004
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT'S AUDITORY PERFORMANCE WAS DECREASED OVERTIME, FOR NO APPARENT REASON. E DEVICE MALFUNCTION IS SUSPECTED AND THE PT'S HEALTHCARE PROVIDER HAS RECOMMENDED THAT PT COCHLEAR IMPLANT BE REPLACED. EXPLANTATION/REIMPLANTATION SURGERY HAS YET TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM 24 CHANNEL COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention