BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5639458 · Received May 9, 2016

    Report

    Report Number
    6000034-2016-00945
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Report Date
    May 23, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DATE OF EXPLANTATION WAS (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON MAY 09, 2016.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED), DUE TO AN INFECTION AT THE IMPLANT SITE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, MAY 09, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296566 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention