BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 9555670 · Received January 6, 2020

    Report

    Report Number
    6000034-2020-00087
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    November 22, 2019
    Report Date
    February 18, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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 07 JANUARY 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POOR PERFORMANCE AS A RESULT OF HEAD TRAUMA; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6)2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13896 NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI422 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention