BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3951161 · Received July 22, 2014

    Report

    Report Number
    6000034-2014-01000
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 30, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SCABBING AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS ON (B)(6) 2014. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427999 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM: PRODUCT CODE MCM COCHLEAR LTD. CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention