BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CONTOUR ADVANCE

    MDR report key: 8829568 · Received July 25, 2019

    Report

    Report Number
    6000034-2019-01358
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    December 3, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED DECEMBER 30, 2019. - ATTACHMENT: [153295 DEVICE ANALYSIS REPORT REG.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 26, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE PATIENT HAS BEEN RE-IMPLANTED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623321 NUCLEUS 24 CONTOUR ADVANCE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE(CA) N/A 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention