BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS

    MDR report key: 2622806 · Received June 11, 2012

    Report

    Report Number
    2622806
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 11, 2012
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY OF SENSORINEURAL HEARING LOSS DUE TO AUDITORY NEUROPATHY. HE UNDERWENT COCHLEAR IMPLANT PLACEMENT ON THE RIGHT. HIS PERFORMANCE WITH THIS DEVICE HAS SUBSEQUENTLY BEEN LESS THAN EXPECTED. MORE RECENTLY, HE HAS BEEN FELT TO HAVE A SOFT FAILURE OF HIS RIGHT COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS IMPLANT COCHLEAR MCM COCHLEAR AMERICAS, INC. CI512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR