BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3802874 · Received May 9, 2014

    Report

    Report Number
    6000034-2014-00696
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS EXPLANTED (B)(6) 2014. THIS REPORT IS FILED (B)(4) 2014. DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS PRESCRIBED A SECOND ROUND OF ORAL ANTIBIOTICS (10 DAY COURSE) ON (B)(6) 2014. THIS REPORT IS FILED (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JULY 29, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE IMPLANT SITE AND WAS PRESCRIBED ORAL ANTIBIOTICS (B)(6), 2014. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280349 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention