BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1962594 · Received January 18, 2011

    Report

    Report Number
    6000034-2011-00030
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    July 1, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; DURING THE SAME SURGERY THE PATIENT WAS IMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; DURING THE SAME SURGERY THE PATIENT WAS IMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED NON-AUDITORY STIMULATION WHEN USING THE INTERNAL DEVICE, RESULTING IN THE DEVICE NON-USE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2011. IT IS SUSPECTED THAT THE DEVICE MAY HAVE BEEN EXPOSED TO ESD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24R (ST) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention