BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 10324500 · Received July 26, 2020

    Report

    Report Number
    6000034-2020-01981
    Event Type
    Injury
    Date Received
    July 26, 2020
    Date of Event
    February 28, 2020
    Report Date
    August 11, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON 2 SEPTEMBER 2020. ATTACHMENT: [160840-DEVICE ANALYSIS REPORT.PDF]

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON 27 JULY 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT IMPLANT SITE RESULTING IN EXPLANT OF THE DEVICE ON (B)(6) 2020. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788628 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention