BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 10268738 · Received July 13, 2020

    Report

    Report Number
    6000034-2020-01768
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 18, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020, DUE TO AN INFECTION AT THE IMPLANT SITE. THERE ARE PLANS TO REIMPLANT THE PATIENT ONCE THE INFECTION HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726592 NUCLEUS CI24RE (CA) FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention