BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST CRANIOTOMY SUBDURAL CATHETER

    MDR report key: 1052235 · Received May 22, 2008

    Report

    Report Number
    2023988-2008-00017
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: ICP VALUES FLUCTUATES DURING THE ZEROING PROCESS OF THE POST CRANIOTOMY SUBDURAL CATHETER, IT CAME WITHIN A RANGE OF 3 TO 7 BUT NEVER COULD BE PLACED TO ACTUAL ZERO. ANOTHER POST CRANIOTOMY SUBDURAL CATHETER WAS OPENED, AND WAS ABLE TO ZERO PRIOR TO INSERTION. A STANDARD RECOMMENDATION FOR THE INSERTION PROCEDURE BEFORE PLACEMENT OF THE DEVICE INTO THE PT IS TO CHECK TO MAKE SURE IT IS ZEROED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST CRANIOTOMY SUBDURAL CATHETER ICP DISPOSABLE GWM INTEGRA NEURO SCIENCES 305000087507

    Patients

    Seq Age Sex Outcome Treatment
    1