BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM

    MDR report key: 1131166 · Received August 20, 2008

    Report

    Report Number
    1131166
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 18, 2008
    Manufacturer
    COCHLEAR AMERICAS
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD SURGERY TO REMOVE A LEFT COCHLEAR IMPLANT DUE TO RECURRENT S. AUREUS INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS FREEDOM COCHLEAR IMPLANT MCM COCHLEAR AMERICAS Z60353

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention