BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL TUNNELING KIT

    MDR report key: 872232 · Received March 15, 2007

    Report

    Report Number
    2023988-2007-00015
    Event Type
    Malfunction
    Date Received
    March 15, 2007
    Report Date
    March 14, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INVOLVED DEVICE HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TWO INCIDENTS IN WHICH AFTER INSERTION OF THE CATHETER, THE INTRACRANIAL PRESSURE (ICP) VALUES WERE NOT RELIABLE. THE USER FACILITY REPLACED THE CATHETER AND THE NEW DEVICE FUNCTIONED PROPERLY. TWO CATHETERS ARE AVAILABLE FOR INVESTIGATION, ONE FROM LOT W051614, THE OTHER FROM UNK LOT NUMBER. NO PT INJURY IS REPORTED. THIS MED DEVICE REPORT IS LINKED WITH MED DEVICE REPORT #2023988-2007-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBDURAL TUNNELING KIT ICP DISPOSABLES GWM INTEGRA NEUROSCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1