BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 12329282 · Received August 16, 2021

    Report

    Report Number
    6000034-2021-02448
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    February 28, 2021
    Report Date
    August 17, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032643
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO SECOND INFECTION. THE INFECTION AND EXPLANT WERE REPORTED IN 6000034-2021-02447. THIS REPORT IS SUBMITTED ON AUGUST 17 2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 17, 2021.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE THAT WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219785 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE N/A 09321502032643

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO Required Intervention