BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3903991 · Received July 1, 2014

    Report

    Report Number
    6000034-2014-00873
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    February 17, 2015
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, SURGERY TO PLACE THE MAGNET BACK INTO PROPER POSITION HAS BEEN COMPLETED ON (B)(6) 2014. THIS REPORT IS FILED FEBRUARY 24, 2015. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT SUBSEQUENT TO SUSTAINING A HEAD INJURY. SURGERY TO REPLACE THE MAGNET IS PLANNED BUT HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382401 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Required Intervention