BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS

    MDR report key: 2150757 · Received July 4, 2011

    Report

    Report Number
    2150757
    Event Type
    Malfunction
    Date Received
    July 4, 2011
    Date of Event
    June 13, 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

    PT. WHO UNDERWENT A COCHLEAR IMPLANT ~13 YEARS AGO FOR PROFOUND DEAFNESS. HE FUNCTIONED REASONABLY WELL WITH HIS IMPLANT, BUT CONTINUED TO BE DISTRESSED REGARDING CONSTANT TINNITUS. HIS DEVICE PERFORMANCE WITH RESPECT TO HEARING PERCEPTION HAS DIMINISHED IN RECENT YEARS, AND HE WAS DIAGNOSED WITH A PARTIAL ELECTRONIC FAILURE 2 YEARS AGO. IT WAS RECOMMENDED THAT HE CONSIDER AN IMPLANT IN HIS LEFT EAR OR AN EXPLANT/REIMPLANT OF THE RIGHT EAR DUE TO THE INTEGRITY TEST RESULTS AND POOR PERFORMANCE. PATIENT IS NOW READY TO PROCEED WITH AN EXPLANT/REIMPLANT OF HIS RIGHT EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS COCHLEAR IMPLANT MCM COCHLEAR AMERICAS CI24M *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR