BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 12215587 · Received July 22, 2021

    Report

    Report Number
    6000034-2021-02209
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    July 2, 2021
    Report Date
    September 10, 2021
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502032643
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT HAS BEEN SUBMITTED ON SEPTEMBER 29, 2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 23, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021, DUE TO THE PATIENT EXPERIENCING A MIDDLE EAR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105452 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI24RE (ST) NA 09321502032643

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention