BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1971128 · Received January 26, 2011

    Report

    Report Number
    6000034-2011-00050
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 14, 2011
    Report Date
    October 5, 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): 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 REIMPLANTED WITH A NEW DEVICE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN LOSS OF CONNECTION THE INTERNAL DEVICE. ATTEMPTS TO CONNECT TO THE DEVICE WERE UNSUCCESSFUL. IT IS UNKNOWN WHETHER THERE ARE PLANS TO EXPLANT AND REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4), 2011.

    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. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention