BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 RCS

    MDR report key: 526404 · Received May 7, 2004

    Report

    Report Number
    MW1032024
    Event Type
    Injury
    Date Received
    May 7, 2004
    Date of Event
    May 3, 2004
    Report Date
    May 6, 2004
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED PROGRESSIVE COCHLEAR IMPLANT ELECTRODE FAILURE. INITIALLY, 2 ELECTRODES FAILED 5 MONTHS AFTER IMPLANTATION, THEN ONE MORE 4 MONTHS LATER, THEN ANOTHER 1 MONTH LATER, THEN 2 MORE 3 MONTHS LATER -APPROX 1 YEAR POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 RCS COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24RCS *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention