BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS

    MDR report key: 9583600 · Received January 13, 2020

    Report

    Report Number
    6000034-2020-00254
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 14, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 14 JANUARY 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO EXTRUSION OF THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46507 NUCLEUS NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention