BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3120931 · Received May 20, 2013

    Report

    Report Number
    6000034-2013-00937
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT HAS BECOME A NON-USER OF THE DEVICE. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221839 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention