BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3870960 · Received June 13, 2014

    Report

    Report Number
    6000034-2014-00808
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 31, 2014
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IMPLANT DATE IS UNKNOWN, NOT MAY 4, 2008 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED SEPTEMBER 1, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED FOR UNSPECIFIED REASONS (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349791 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI422

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention