BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2942782 · Received February 4, 2013

    Report

    Report Number
    6000034-2013-00247
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 3, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. THIS REPORT IS FILED OCTOBER 11, 2013. DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, A CT SCAN (DATE NOT REPORTED), REVEALED A CEREBROSPINAL FLUID LEAK. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2013. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. IT WAS ALSO REPORTED THAT THE ETIOLOGY OF DEAFNESS WAS MENINGITIS. THIS REPORT IS FILED DECEMBER 12, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2012, UNTIL (B)(6) 2013, DUE TO MENINGITIS POST-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46297 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA Hospitalization| R