BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3780753 · Received April 30, 2014

    Report

    Report Number
    6000034-2014-00627
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 6, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THE EPISODE OF MENINGITIS: ETIOLOGY OF DEAFNESS - INNER EAR ANOMALY DUE TO PRE-IMPLANT HISTORY OF MENINGITIS. NO CEREBROSPINAL FLUID LEAK OCCURRED DURING ANY SURGICAL INTERVENTION. THE PATIENT RECEIVED PRE IMPLANTATION IMMUNIZATION (TYPE NOT REPORTED). THE PATIENT EXPERIENCED AN INFECTION (TYPE NOT REPORTED) PRIOR TO THE CURRENT MENINGITIS EPISODE. PNEUMOCOCCUS WAS IDENTIFIED (SOURCE NOT REPORTED). PATIENT WAS HOSPITALIZED FOR TWO WEEKS (DATE NOT REPORTED) DUE TO CURRENT MENINGITIS EPISODE AND WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS. PRIOR TO COCHLEAR IMPLANT SURGERY THE PATIENT WAS TREATED WITH CEPHALOSPORIN AND AUGMENTIN (DATE NOT REPORTED). NO SURGICAL COMPLICATION DURING IMPLANT SURGERY OCCURRED. THE PATIENT RECOVERED. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE. THIS REPORT IS FILED JUNE 5, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2014, DUE TO MENINGITIS (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259367 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| L| R