BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1447245 · Received August 24, 2009

    Report

    Report Number
    6000034-2009-00578
    Event Type
    Injury
    Date Received
    August 24, 2009
    Date of Event
    July 24, 2009
    Report Date
    July 27, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT HAD A SEIZURE AND WAS HOSPITALIZED FOR MENINGITIS. THE RESULTS OF A CT SCAN INDICATE NO FLUID IN THE MIDDLE EAR OR AROUND THE IMPLANT. THE PATIENT HAS A HISTORY OF SIGNIFICANT SINUS ISSUES AND A CSF LEAK RELATED TO THIS ISSUE. PER THE PHYSICIAN, THE CSF LEAK LIKELY CAUSED THE MENINGITIS. MORE INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT AUGUST 21, 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention