BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3040856 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00630
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 POOR PERFORMANCE WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT HAS DISCONTINUED USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143541 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention