BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8471720 · Received April 1, 2019

    Report

    Report Number
    6000034-2019-00500
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 19, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032599
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 02, 2019.

    Description of Event or Problem · 1

    PER THE PATIENT'S SURGEON, THE PATIENT EXPERIENCED A NON-DEVICE RELATED INFECTION RESULTING IN EXPLANT OF THE DEVICE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265071 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 N/A 09321502032599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention