BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1161623 · Received September 15, 2008

    Report

    Report Number
    6000034-2008-00523
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 11, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    A NEW CASE OF MENINGITIS WAS REPORTED TO COCHLEAR AMERICAS ON SEPTEMBER 11, 2008. PER THE AUDIOLOGIST, THE PATIENT HAD TWO BOUTS OF PNEUMOCOCCENMENINGITIS IN 2007 AND AT ABOUT 4 MONTHS LATER, PRIOR TO BEING IMPLANTED. DURING IMPLANT SURGERY AT ABOUT 2 MONTHS LATER, MULTIPLE FLUID LEAKS WERE OBSERVED IN THE MIDDLE EAR. THE MIDDLE EAR WAS CLOSED OFF COMPLETELY. THE PATIENT WAS TREATED WITH AMOXICILLINE FOR ONE WEEK, THEN WITH BACTRIMELPROFYLAXE UNTIL APPROXIMATELY 2 MONTHS LATER. IN 2008, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A THIRD CASE OF PNEUMOCOCCENMENINGITIS. THE PATIENT WAS TREATED WITH CEFTRIAXON AND PENIG AND REPORTEDLY RESPONDED WELL. IT IS ANTICIPATED THE PATIENT WILL BE TREATED WITH ANTIBIOTICAPROFYLAXE. DUE TO THE COMPLETE CLOSURE OF THE MIDDLE EAR, THERE IS NO SURGICAL INTERVENTION PLANNED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening