BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8388541 · Received March 4, 2019

    Report

    Report Number
    6000034-2019-00278
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Report Date
    August 6, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED ON MAY 29, 2019.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS INDICATES A DEVICE FAILURE. THIS REPORT IS SUBMITTED SEPTEMBER 02, 2019. - ATTACHMENT: [142811 DEVICE ANALYSIS REPORT.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND SWELLING AT IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED) FOR A DURATION OF 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181991 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention