BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1260104 · Received December 3, 2008

    Report

    Report Number
    6000034-2008-00693
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 1, 2008
    Report Date
    December 2, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT'S FATHER REPORTED THE PATIENT WAS HOSPITALIZED IN 2008 (DATE NOT REPORTED) WITH MENINGITIS. REPORTEDLY, THE PATIENT HAS BILATERAL MONDINI MALFORMATIONS. FURTHER INFORMATION HAD BEEN REQUESTED AT THE TIME OF THIS REPORT FILED 2008.

    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 3 YR Life Threatening