BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8877099 · Received August 8, 2019

    Report

    Report Number
    6000034-2019-01381
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 15, 2019
    Report Date
    February 14, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON MARCH 14, 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 09, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669319 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NI 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention