BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS

    MDR report key: 2153240 · Received July 4, 2011

    Report

    Report Number
    2153240
    Event Type
    Malfunction
    Date Received
    July 4, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 4, 2011
    Manufacturer
    COCHLEAR AMERICAS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WHO UNDERWENT IMPLANTATION ON THE RIGHT WITH A NUCLEUS FREEDOM DEVICE ELSEWHERE ~5 YEARS AGO. PATIENT SUBSEQUENTLY WAS IMPLANTED IN THE LEFT EAR WITH A NUCLEUS FREEDOM DEVICE ~3 YEARS AGO. PATIENT'S PERFORMANCE WITH THE RIGHT-SIDED DEVICE HAS DETERIORATED AND HE HAS BEEN FOUND TO HAVE ELECTRODE SHUNTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR