BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBDURAL TUNNELING ICP MONITORING KIT

    MDR report key: 2003565 · Received February 22, 2011

    Report

    Report Number
    2023988-2011-00003
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 22, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF THREE REPORTS INVOLVING A SUBDURAL TUNNELING ICP MONITORING KIT ((B)(4)) [SAME PRODUCT LOT NUMBER USED BY THE SAME USER FACILITY, SAME PHYSICIAN'S ASSISTANT WHO IMPLANTED THE CATHETERS, SAME ADVERSE EVENT EXPERIENCED, DIFFERENT PATIENTS]. A (B)(6) MALE PATIENT WITH AN INTRACRANIAL BLEED DUE TO TRAUMA WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011. THE PATIENT HAD THE CATHETER IMPLANTED ON (B)(6) 2011 FOR A LOW GLASGOW COMA SCORE. DURING A ROUTINE MONITORING OF THE PATIENT'S CEREBRAL SPINAL FLUID (CSF) ON (B)(6) 2011, IT WAS DISCOVERED THAT THE PATIENT HAD VENTRICULITIS THROUGH A POSITIVE CSF CULTURE. THE TYPE OF BACTERIA FOUND ON THE CSF CULTURE WAS REPORTED AS (B)(6). THE CATHETER WAS REMOVED ON (B)(6) 2011 AND WAS CHANGED TO ANOTHER CATHETER (CODMAN BACTISEAL). THE PATIENT REMAINS COMATOSE AND FEBRILE IN THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE "CSF IS BETTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBDURAL TUNNELING ICP MONITORING KIT NA GWM INTEGRA NEUROSCIENCES SD 305000156402

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR