BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-VENTRICULOSTOMY RESERVOIR, BURR HOLE, 6MM

    MDR report key: 9173079 · Received October 9, 2019

    Report

    Report Number
    2021898-2019-00361
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    November 14, 2018
    Report Date
    October 9, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K874498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF THE INTRACEREBRAL VENTRICULOSTOMY (ICV) SET ON (B)(6) 2016. ON (B)(6) 2016,<(>,<)> THE PATIENT INITIATED TREATMENT WITH BMN 250 (100 MILLIGRAM, QW, ICV). ON (B)(6) 2018, THE PATIENT'S BMN 250 WAS ADMINISTERED, AND ON (B)(6) 2018, THE PATIENT HAD A FEVER (MAXIMUM OF 38.7ºC) AND WAS VOMITING. THE EMERGENCY DEPARTMENT OBSERVED RIGIDITY OF THE PATIENT'S NECK AND SWELLING OF THE ICV. ALSO THE PATIENT SEEMED TO HAVE PAIN WHEN TOUCHING THE ICV AND ALTERNATE EPISODES OF DROWSINESS. GRADE 3 MENINGITIS WAS SUSPECTED AND A BLOOD TEST WAS PERFORMED WITH NORMAL RESULT (SHORT EVOLUTION TIME). A CEREBROSPINAL FLUID (CSF) SAMPLE WAS OBTAINED FROM THE RESERVOIR, WHICH WAS TURBID. THE HOSPITAL ADMISSION WAS DECIDED AND INTRAVENOUS ANTIBIOTIC THERAPY WITH CEFOTAZIME AND VANCOMYCIN WAS STARTED. ON (B)(6) 2018, IN THE MORNING THE PATIENT ONLY PRESENTED WITH LOW-GRADE FEVER. GIVEN THAT THE ANALYSIS OF CSF INCLUDING GRAM WAS NEGATIVE, IT WAS DECIDED TO PERFORM A LUMBAR PUNCTURE THAT SHOWED CELL ELEVATION (AROUND 1000/ML) AT THE EXPENSE OF POLYMORPHONUCLEAR CELLS AND HYPOGLYCORRHACHIA. IT WAS DECIDED TO REMOVE THE ICV DEVICE BY SURGERY AND THE PATIENT CONTINUED WITH INTRAVENOUS ANTIBIOTICS FOR APPROXIMATELY 15 DAYS PENDING THE RESULT OF THE CULTURES. A BRAIN NUCLEAR MAGNETIC RESONANCE IMAGING WAS ALSO PERFORMED AND IT DID NOT SHOW SIGNIFICANT ALTERATIONS OR INTRACRANIAL COMPLICATIONS SUCH AS ABSCESS OR OBSTRUCTION TO THE CIRCULATION OF CEREBROSPINAL FLUID. TREATMENT WITH BMN 250 AND THE ICV DEVICE WAS WITHDRAWN DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON (B)(6) 2018. THE INVESTIGATOR UPDATED THE PRIMARY EVENT FROM MENINGITIS TO DEVICE RELATED INFECTION. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BMN 250. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS RELATED TO THE SUBJECT'S ICV DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967380 CSF-VENTRICULOSTOMY RESERVOIR, BURR HOLE, 6MM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R