BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3914336 · Received July 3, 2014

    Report

    Report Number
    6000034-2014-00934
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    July 25, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY (B)(6) 2014 TO REPOSITION THE DEVICE AND WAS PRESCRIBED A 30 DAY COURSE OF ORAL ANTIBIOTICS AFTER 2 DAYS OF IV ANTIBIOTICS POST-SURGERY. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED JUNE 26, 2014. THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE RECEIVER STIMULATOR UNIT SUBSEQUENT TO SUSTAINING HEAD TRAUMA. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390425 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention