BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 5

    MDR report key: 3091417 · Received April 24, 2013

    Report

    Report Number
    3091417
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COCHLEAR AMERICAS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN IN PREVIOUSLY BY OUR ENT CLINIC AND AUDIOLOGIST FOUND NO COMMUNICATION WITH RIGHT EAR COCHLEAR IMPLANT. DEVICE MANUFACTURER WAS NOTIFIED AND CLINICAL ENGINEER CONFIRMED THAT THE CLINICAL SITUATION WAS CONSISTENT WITH DEVICE FAILURE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER.======================MANUFACTURER RESPONSE FOR COCHLEAR IMPLANT, NUCLEUS 5 COCHLEAR IMPLANT (PER SITE REPORTER).======================MANUFACTURER IS AWAITING RETURN FOR ADDITIONAL TESTING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176432 NUCLEUS 5 COCHLEAR IMPLANT MCM COCHLEAR AMERICAS C1512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR