BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 15757310 · Received November 8, 2022

    Report

    Report Number
    6000034-2022-03481
    Event Type
    Injury
    Date Received
    November 8, 2022
    Report Date
    October 19, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 09, 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO UNSPECIFIED MEDICAL REASON (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2946538 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention