BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CONTOUR

    MDR report key: 8319096 · Received February 7, 2019

    Report

    Report Number
    6000034-2019-00145
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Report Date
    May 21, 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

    ADDITIONAL: IT HAS SINCE BEEN REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2019 TO EXPLANT THE DEVICE. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED ON MAY 16, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON JUNE 18, 2019. - ATTACHMENT: [142362-DEVICE ANALYSIS REPORT.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 08, 2019.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE WITH AND WITHOUT STIMULATION. THE PATIENT WAS HOSPITALIZED AND ANTIBIOTICS WERE ADMINISTERED (TYPE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS AND THE PATIENT IS BEING CLINICALLY MANAGED BY THE HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111699 NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24R(CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R