BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3974711 · Received August 4, 2014

    Report

    Report Number
    6000034-2014-01045
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 27, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(6) 2016.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A DECREMENT OF ELECTRODE FUNCTION; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454603 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention