BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBDURAL TUNNELING ICP MONITORING KIT

    MDR report key: 2003567 · Received February 22, 2011

    Report

    Report Number
    2023988-2011-00004
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 11, 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 THIRD 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) FEMALE PATIENT WITH A RUPTURE BASILAR TIP ANEURYSM WAS ADMITTED TO THE HOSPITAL ON (B)(6)2011. THE PATIENT HAD THE CATHETER IMPLANTED ON (B)(6) 2011 FOR OBSTRUCTIVE HYDROCEPHALUS. 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 PATIENT WAS GIVEN ANTIBIOTICS INTRAVENOUSLY AND INTRATHECALLY. THE CATHETER WAS REMOVED ON (B)(6) 2011 AND WAS CHANGED TO A DIFFERENT CATHETER (CODMAN BACTISEAL). THE PATIENT REMAINS IN THE HOSPITAL BUT THE CSF HAS IMPROVED.

    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 56 YR