BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA SHUNT II

    MDR report key: 1152423 · Received September 5, 2008

    Report

    Report Number
    1152423
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC NEUROLOGICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PATIENT WITH MULTIPLE PROBLEMS INCLUDING CARDIAC (REQUIRING PACEMAKER) AND HYDROCEPHALUS (REQUIRING VP SHUNT PLACEMENT). SEVERAL WEEKS LATER, NEUROSURGERY WAS ASKED TO TAP SHUNT BECAUSE OF INCREASED FEVER AND INCREASED WBC AND WHEN THEY DID - THEY GOT BACK LOW VOLUME. A CT SCAN WAS ORDERED AND RESULT INDICATED MASSIVE OVER DRAINAGE AND DECOMPRESSION OF THE THIRD AND LATERAL VENTRICLES WITH ACUTE OR CHRONIC SUBDURAL HEMATOMAS. PROGRAMMABLE SETTING OF SHUNT VALVE WAS CHECKED AND THE SETTING FOUND TO BE OPEN - AT THE LOWEST SETTING. THIS HAD NOT BEEN CHANGED BY CLINICIANS (LAST CHANGE HAD BEEN AROUND ONE MONTH FROM IMPLANT FROM A SETTING OF 1 TO 1.5). THE SETTING WAS IMMEDIATELY CHANGED TO CLOSED. CT SCAN A FEW DAYS LATER SHOWS IMPROVEMENT IN THE SIZE OF VENTRICLES AND SLIGHT DECREASE IN SIZE OF SUBDURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA SHUNT II SHUNT, VENTRICULOPERITONEAL, PROGRAMMABLE JXG MEDTRONIC NEUROLOGICAL * C00329

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention