BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3895511 · Received June 25, 2014

    Report

    Report Number
    6000034-2014-00929
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 13, 2014
    Report Date
    February 23, 2015
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2014. THIS REPORT IS FILED (B)(6), 2015.

    Description of Event or Problem · 1

    PER THE CLINIC, PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE RESULTING IN EXPOSURE OF THE IMPLANT. THE PATIENT WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE, DURATION AND DOSAGE NOT REPORTED). THE IMPLANTED DEVICE REMAINS. EXPLANTATION AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT, (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370231 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention