BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3020023 · Received March 25, 2013

    Report

    Report Number
    6000034-2013-00529
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 14, 2013
    Report Date
    July 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. 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)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122868 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention