BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2981771 · Received February 27, 2013

    Report

    Report Number
    6000034-2013-00352
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 5, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON 14 FEB 2014.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013. DUE TO INFECTION IDENTIFIED AT IMPLANT SITE DURING EXPLANTATION, REIMPLANTED HAS BEEN POSTPONED UNTIL INFECTION CLEARS. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT AN MRI SCAN (DATE NOT REPORTED) WITHOUT REMOVING THE INTERNAL MAGNET. SUBSEQUENTLY, THE INTERNAL MAGNET BECAME DISLODGED, LEADING TO DEVICE NON-USE. IT WAS ALSO REPORTED THAT THE ELECTRIC COMPONENTS OF THE INTERNAL DEVICE HAD FAILED. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84306 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention