BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS

    MDR report key: 194489 · Received February 7, 1997

    Report

    Report Number
    1721493-1997-00012
    Event Type
    Injury
    Date Received
    February 7, 1997
    Date of Event
    December 16, 1996
    Report Date
    January 17, 1997
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PT PREVIOUSLY HAD AN INFECTION IN HER SKIN FLAP. THIS INFECTION WAS TREATED. ON 12/09/1996 THE PT'S NONFUNCTIONAL INERAID DEVICE WAS EXPLANTED AND A NUCLEUS 22 CHANNEL COCHLEAR IMPLANT WAS IMPLANTED. THE PT DEVELOPED A SKIN FLAP INFECTION APPROX ONE WEEK LATER. THE PT WAS HOSPITALIZED AND TREATD WITH INTRAVENOUS ANTIBIOTICS. SHE WAS RELEASED FROM THE HOSP AND CONTINUED ANTIBIOTIC TREATMENT AT HOME. THE SURGEON REPORTED THAT THE PT WAS RECOVERING WELL. THE HEALTH CARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEIVCE 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 49 YR Required Intervention