BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3831611 · Received May 26, 2014

    Report

    Report Number
    6000034-2014-00756
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    March 12, 2014
    Report Date
    May 6, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE, HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309884 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention