BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE

    MDR report key: 2764266 · Received September 26, 2012

    Report

    Report Number
    2021898-2012-00301
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    January 14, 2011
    Report Date
    August 28, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE AUTHOR COMMENTED THAT THE HIGH FREQUENCY OF HEMATOMAS WAS THOUGHT TO HAVE OCCURRED AS A RESULT OF USING TOO LOW OF AN OPENING PRESSURE SETTING (1.0). HOWEVER, THIS SETTING WAS SPECIFICALLY CHOSEN FOR THE STUDY, AND NOT NECESSARILY TO THE PATIENT'S PHYSIOLOGY. IN ADDITION, SEVERAL PATIENTS WERE ON ANTIPLATELET MEDICATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE EVALUATIONS OF DEVICE PERFORMANCE WERE NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS LOT NUMBERS WERE NOT PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. MAGNUSTISSEL ET. AL. SHUNT SURGERY IN PATIENTS WITH HYDROCEPHALUS AND WHITE MATTER CHANGES. J NEUROSURG 114:1432-1438, 2011.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE INCLUDED A STUDY IN WHICH A GROUP OF 14 PATIENTS WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS WERE RANDOMIZED TO SURGICAL TREATMENT WITH OPEN OR LIGATED SHUNTS. STRATA VALVES WITH A PRESSURE SETTING OF 1.0 WERE USED FOR THE STUDY. ACCORDING TO THE ARTICLE, FIVE PATIENTS SUFFERED FROM SUBDURAL HEMATOMAS. FOUR OF THE HEMATOMAS DISAPPEARED AFTER UPREGULATION OF THE VALVE FROM PRESSURE SETTING 1.0 TO 1.5 OR 2.0. FIFTH HEMATOMA BECAME SYMPTOMATIC AND WAS SURGICALLY EVACUATED. AFTER WHICH THE PATIENT RECOVERED COMPLETELY. THREE PATIENTS SUFFERED FROM ISCHEMIC STROKE: 1 MAJOR AND 2 MINOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA VALVE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention