BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8669111 · Received June 4, 2019

    Report

    Report Number
    6000034-2019-00919
    Event Type
    Injury
    Date Received
    June 4, 2019
    Report Date
    May 21, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032599
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE TIP OF THE ELECTRODE ARRAY WAS PARTIALLY INSERTED AND FOUND TO BE FOLDED OVER IN THE COCHLEA, SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO RE-POSITION THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461502 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 NI 09321502032599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention