BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 15408322 · Received September 13, 2022

    Report

    Report Number
    6000034-2022-02650
    Event Type
    Injury
    Date Received
    September 13, 2022
    Report Date
    September 16, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON SEPTEMBER 13, 2022.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON OCTOBER 13, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN AND AN INFECTION AT THE RECEIVER STIMULATOR (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED OVERNIGHT ON (B)(6) 2022 AND WAS TREATED WITH IV ANTIBIOTICS, TO HAVE THE SITE CLEANED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2022. THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666477 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI24RE (CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention