BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3831609 · Received May 26, 2014

    Report

    Report Number
    6000034-2014-00786
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE (SPECIFIC DATE NOT REPORTED), AND WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE, DURATION AND DOSAGE NOT REPORTED), THE SYMPTOMS RESOLVED. THE ISSUE RECURRED ON (B)(6), 2014 AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE, DURATION AND DOSAGE NOT REPORTED.) THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309915 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RST

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention