BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 6452515 · Received April 3, 2017

    Report

    Report Number
    6000034-2017-00656
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    October 18, 2016
    Report Date
    April 7, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 21, 2017.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 03, 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2016, FOR TREATMENT OF A BRAIN TUMOUR. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, APRIL 03, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236405 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE(CA) N/A 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention