BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1945984 · Received January 4, 2011

    Report

    Report Number
    6000034-2010-00819
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    February 22, 2010
    Report Date
    March 28, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2010 TO TREAT AN EXPOSURE OF THE RECEIVER/STIMULATOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED IN (B)(6), 2008 TO DRAIN A HEMATOMA AROUND THE SITE OF THE RECEIVER/STIMULATOR SUBSEQUENT TO A HEAD TRAUMA. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R