BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2080455 · Received April 22, 2011

    Report

    Report Number
    1226348-2011-00169
    Event Type
    Injury
    Date Received
    April 22, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE DEVICE WAS INSERTED INTO THE PT THE DEVICE GAVE ERRATIC READINGS, BOTH NEGATIVE AND POSITIVE. AFTER 2-4 DAYS THE DEVICE WAS REMOVED AND THE TIP WAS FRACTURED. CUSTOMER NOT SURE IF IT OCCURRED DURING IMPLANT OR EXPLANT. PART OF THE TIP REMAINED IN THE PT'S HEAD AND NEEDED TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NA 500284

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention