BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3081921 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00755
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013, FOR THE REMOVAL OF TITANIUM MESH PLACED DURING IMPLANTATION TO SECURE THE DEVICE. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED BREAKDOWN OF SKIN FLAP TISSUE ABOVE THE RECEIVER/STIMULATOR (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND 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
    185328 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention