BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2160989 · Received October 17, 2008

    Report

    Report Number
    2160989
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAD A PT THAT HAD A NEUROSCIENCES CAMINO COMPLETE MICRO VENTRICULAR BOLT PRESSURE MONITORING AND DRAINAGE KIT THAT WAS NOT WORKING PROPERLY AND NEEDED TO BE REMOVED. DURING THE REMOVAL, THE END PIECE OF THE BOLT BROKE OFF AND A PORTION REMAINED LODGED IN THE PT'S SKULL. THE SURGEON MADE A CONSCIOUS DECISION TO NOT REMOVE THE RETAINED PORTION OF THE BOLT BUT RATHER, PLACED A NEW KIT. THE SURGEON FELT THE BOLT THAT WAS REMOVED MAY HAVE BEEN DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICRO VENTRICULAR BOLT PRESSURE MONITOR GWM INTEGRA NEUROSCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR