BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 6015810 · Received October 10, 2016

    Report

    Report Number
    6000034-2016-01962
    Event Type
    Injury
    Date Received
    October 10, 2016
    Report Date
    September 16, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AND INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT IS SUBMITTED ON OCTOBER 11, 2016 BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 1, 2016 BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. CORRECTION: THE DATE OF THIS REPORT IS 09/16/2016; NOT 09/15/2016 AS PREVIOUSLY REPORTED. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED CEREBROSPINAL FLUID LEAKAGE AT IMPLANT SITE; SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY TO REPOSITION THE ELECTRODE AND REPAIR THE CEREBROSPINAL FLUID LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665953 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI422 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention