BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 640547 · Received October 13, 2005

    Report

    Report Number
    6000034-2005-00306
    Event Type
    Injury
    Date Received
    October 13, 2005
    Date of Event
    July 12, 2005
    Report Date
    October 13, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 7 YEARS OF SUCCESSFUL COCHLEAR IMPLANT USE, THIS PT REPORTEDLY BEGAN TO EXPERIENCE CHANGES IN STIMULATION REQUIREMENTS AND PAIN WHILE USING HIS DEVICE. EXPLANTATION AND REIMPLANTABLE SURGERY TOOK PLACE IN 07/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24M *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention