BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8942761 · Received August 28, 2019

    Report

    Report Number
    6000034-2019-01560
    Event Type
    Injury
    Date Received
    August 28, 2019
    Report Date
    November 26, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INFECTION PRIOR TO EXPLANTING THE DEVICE. THIS REPORT IS SUBMITTED 11 NOVEMBER 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED DECEMBER 23, 2019. - ATTACHMENT: [150657 DEVICE ANALYSIS REPORT REG.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 29, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND PERFORMANCE DECREMENT WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735916 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 N/A 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention