BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 9584452 · Received January 13, 2020

    Report

    Report Number
    6000034-2020-00277
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 27, 2019
    Report Date
    May 16, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS INDICATED DEVICE FAILURE. THIS REPORT IS SUBMITTED OM JUNE 11, 2024.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019, DUE TO SHORT CIRCUITED ELECTRODES. THE PATIENT WILL BE REIMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46852 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Required Intervention| O