BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2905587 · Received January 9, 2013

    Report

    Report Number
    6000034-2013-00074
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, AN ABSCESS DEVELOPED AROUND THE IMPLANT SITE, AND WAS TREATED WITH SURGICAL CLEANSING AND ANTIBIOTICS (TYPE AND DATE NOT REPORTED). THE ISSUE COULD NOT BE RESOLVED.THE DEVICE WAS EXPLANTED (B)(6), 2012. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11426 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention