BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 11008520 · Received December 15, 2020

    Report

    Report Number
    6000034-2020-03442
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 4, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502025690
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS FOLLOW-UP REPORT IS TO ADD INVESTIGATION, FINDING, AND CONCLUSION CODES AS PER DAR PROVIDED IN MFG REPORT NUMBER 6000034-2020-03442. THIS REPORT IS SUBMITTED ON DECEMBER 15, 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON DECEMBER 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND EXTRUSION OF THE RECEIVER/STIMULATOR. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THE PATIENT HAS BEEN REIMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479952 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502025690

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention