BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1260103 · Received December 3, 2008

    Report

    Report Number
    6000034-2008-00692
    Event Type
    Death
    Date Received
    December 3, 2008
    Date of Event
    November 1, 2008
    Report Date
    December 1, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED, DECEMBER 03, 2008.

    Description of Event or Problem · 1

    A NEW CASE OF MENINGITIS WAS REPORTED TO COCHLEAR AMERICAS IN 2008. PER THE AUDIOLOGIST, THE PATIENT WAS ADMITTED TO THE HOSPITAL IN 2007, (EXACT DATE NOT REPORTED) WITH MENINGITIS AND THEN AGAIN IN 2008, (EXACT DATE NOT REPORTED). THE SURGEON REPORTED THAT "THE MENINGITIS WAS UNRELATED TO THE IMPLANT", BUT RELATED TO A COMMON CAVITY MALFORMATION IN THE CONTRALATERAL EAR. THE PATIENT DIED IN 2008. PER THE SURGEON, THE DEATH WAS UNRELATED TO THE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death