BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22

    MDR report key: 22857719 · Received August 21, 2025

    Report

    Report Number
    6000034-2025-03135
    Event Type
    Injury
    Date Received
    August 21, 2025
    Report Date
    September 30, 2025
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX E HAS BEEN UPDATED WITH CODE 2103 (TINNITUS), AND ANNEX F HAS BEEN UPDATED WITH CODE 4653 (REPROGRAMMING OF THE DEVICE).

    Description of Event or Problem · 0

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATYPICAL SOUND PERCEPTS, PAIN, TINNITUS AND SHORT CIRCUIT. HARDWARE EXCHANGE AND REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT ALSO EXPERIENCED EXTRUSION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE IS STILL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419229 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention