BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 643619 · Received October 28, 2005

    Report

    Report Number
    6000034-2005-00321
    Event Type
    Injury
    Date Received
    October 28, 2005
    Date of Event
    October 1, 2003
    Report Date
    October 28, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    AFTER 7 YEARS OF COCHLEAR IMPLANT USE, THIS PT REPORTEDLY EXPERIENCED A DECLINE IN PERFORMANCE. HIS EXTERNAL EQUIPMENT WAS SWAPPED OUT AND HIS DEVICE WAS REPROGRAMMED. HOWEVER, THE PROBLEM WAS NOT RESOLVED. HE WAS SCHEDULED FOR EXPLANTATION/REIMPLANTATION SURGERY IN 10/24/2005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention