BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 10269076 · Received July 14, 2020

    Report

    Report Number
    6000034-2020-01888
    Event Type
    Injury
    Date Received
    July 14, 2020
    Report Date
    May 11, 2020
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT DATE OF AWARENESS IS MAY 11, 2020; NOT APRIL 15, 2020 AS PREVIOUSLY REPORTED ON JULY 14, 2020. DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON MAY 16, 2024.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED OEDEMA AND INFECTION AT THE IMPLANT SITE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734996 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI24RE(CA) N/A 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention