BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3219844 · Received July 10, 2013

    Report

    Report Number
    6000034-2013-01273
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    July 5, 2013
    Report Date
    November 19, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE EXPLANTED DATE IS (B)(6) 2013; NOT (B)(6) 2013, AS PREVIOUSLY REPORTED. THIS REPORT IS FILED NOVEMBER 25, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED FACIAL NERVE STIMULATION WITH DEVICE USE.THE DEVICE WAS EXPLANTED ON (B)(6), 2013. REIMPLANTATION IS NOT PLANNED AT THE TIME OF THIS REPORT, (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314734 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RST

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention