BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22

    MDR report key: 22041448 · Received May 18, 2025

    Report

    Report Number
    6000034-2025-01748
    Event Type
    Injury
    Date Received
    May 18, 2025
    Date of Event
    April 22, 2025
    Report Date
    August 6, 2025
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P890027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION G4: CORRECT PMA/510(K) IS P890027, NOT P840024 AS PREVIOUSLY REPORTED IN THE INITIAL REPORT [6000034-2025-01748]. DEVICE ANALYSIS REPORT ATTACHED.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO NEED FOR MRI AND THE PATIENT BECAME A NON-USER OF THE DEVICE. THE PATIENT ALSO RECEIVED NO BENEFIT FROM THE DEVICE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051084 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention