BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8762962 · Received July 4, 2019

    Report

    Report Number
    6000034-2019-01120
    Event Type
    Injury
    Date Received
    July 4, 2019
    Date of Event
    June 14, 2019
    Report Date
    August 30, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED SEPTEMBER 12, 2019.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556563 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention