BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 15256583 · Received August 19, 2022

    Report

    Report Number
    6000034-2022-02393
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 23, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 19, 2022.

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE PATIENT UNDERWENT MAGNET REPLACEMENT SURGERY ON (B)(6) 2022, UNDER GENERAL ANAESTHETIC. THIS REPORT IS SUBMITTED ON SEPTEMBER 19, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DUE TO A HEAD IMPACT (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790554 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Required Intervention