BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512

    MDR report key: 2967725 · Received February 10, 2013

    Report

    Report Number
    2967725
    Event Type
    Malfunction
    Date Received
    February 10, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 8, 2013
    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 STATUS POST RIGHT COCHLEAR IMPLANT ABOUT TWO YEARS AGO, WITH A COCHLEAR CORPORATION NUCLEUS CI512 DEVICE. PATIENT AND HIS WIFE INDICATE THAT FOLLOWING ACTIVATION OF HIS IMPLANT, HE HAD A VERY SERVICEABLE HEARING ON THE RIGHT SIDE. HOWEVER, ABOUT SEVEN MONTHS LATER, HE HAD AN EPISODE WHERE HE NOTICED THE IMPLANT SHUT OFF FOR A SECOND AND THEN CAME BACK ON. HE THEN STATED THAT HE NOTICED A DECREASE IN HIS ABILITY TO HEAR ON THE RIGHT. HE STATES THAT HE CANNOT HEAR WITH THE COCHLEAR IMPLANT BY ITSELF AND THAT HE NEEDS A COCHLEAR IMPLANT AND HEARING AID TOGETHER IN ORDER TO HAVE SERVICEABLE HEARING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT COCHLEAR EXPLANT AND REIMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57907 NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS INC. CI512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR