BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8774584 · Received July 10, 2019

    Report

    Report Number
    6000034-2019-01213
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 29, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND RECEIVED AT COCHLEAR ON AUGUST 09, 2019. EVALUATION IN PROGRESS. THIS REPORT IS FILED ON AUGUST 15, 2019.

    Description of Event or Problem · 0

    THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND RECEIVED AT COCHLEAR ON AUGUST 09, 2019. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 10, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE ELECTRODE IS EXTRUDING THROUGH THE SKIN. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568038 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R