BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2130704 · Received June 16, 2011

    Report

    Report Number
    6000034-2011-00413
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 23, 2011
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(4), 2011.THIS REPORT IS FILED DECEMBER 2, 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A BLOW TO THE HEAD, RESULTING IN THE MAGNET BECOMING DISLODGED. REVISON SURGERY TO REPLACE THE MAGNET IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT, (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24R (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention