BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3081860 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00745
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT AN EXPLANT SURGERY ON (B)(6) 2013. THE PROCEDURE REVEALED DISLODGMENT OF THE INTERNAL MAGNET. THE DISLODGED MAGNET WAS PUT BACK INTO PLACE DURING THE SAME PROCEDURE AND INTRA-OPERATIVE TESTING PROVIDED PROPER RESPONSE. NO FURTHER ISSUE WERE REPORTED AND THE PATIENT RESUMED USE OF THE DEVICE. THE IMPLANT STAYED IN-SITU AT ALL TIMES. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND LOSS OF CONNECTION TO THE INTERNAL DEVICE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE IMPLANTED DEVICE REMAINS.IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184950 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention