BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS

    MDR report key: 194275 · Received November 7, 1996

    Report

    Report Number
    1721493-1996-00008
    Event Type
    Injury
    Date Received
    November 7, 1996
    Date of Event
    October 30, 1996
    Report Date
    November 7, 1996
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT DEVELOPED OTITIS MEDIA AT SOME TIME POST IMPLANT SURGERY. OUTPATIENT ANTIBIOTIC THERAPY WAS NOT SUCCESSFUL. ON 9/25/96 THE PT WAS ADMITTED TO THE HOSP FOR INTRAVENOUS ANTIBIOTIC TREATMENT FOR A MIDDLE EAR AND MASTOID INFECTION. STAPHYLOCCOCCUS WAS CULTURED. THE INFECTION CLEARED AND THE PT WAS DISCHARGED ON 10/11/96. THE INFECTION REOCCURRED AND THE PT UNDERWENT DEVICE EXPLANTATION AND A MODIFIED RADICAL MASTOIDECTOMY ON 10/30/96. THE HEALTH CARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS Implant 22 CHANNEL COCHLEAR IMPLANT FOR ADULTS MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention