BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2870128 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02322
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    September 28, 2012
    Report Date
    March 26, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A SKIN FLAP INFECTION AND WAS TREATED WITH FOUR SEPARATE COURSES OF ORAL ANTIBIOTICS BETWEEN (B)(6) 2012. ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY TO REPOSITION THE DEVICE AND WAS IMPLANTED WITH A NEW DEVICE IN THE CONTRALATERAL EAR DURING THE SAME SURGERY. ON (B)(6) 2012, THE PATIENT DEVELOPED A WOUND DEHISCENCE AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2012, DUE TO INFECTION. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE MCM MCM COCHLEAR LTD. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention