BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCELUS CONTOUR

    MDR report key: 2013226 · Received March 6, 2011

    Report

    Report Number
    2013226
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 6, 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

    PATIENT UNDERWENT COCHLEAR IMPLANTATION 5-1/2 YEARS AGO. HER IMPLANT HAS BEEN MALFUNCTIONING AND SHE HAD DETERIORATION OF VOCABULARY. A DECISION WAS THEN MADE TO PROCEED WITH EXPLANTATION AND REIMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCELUS CONTOUR COCHLEAR IMPLANT MCM COCHLEAR AMERICAS CI24R *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR