BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 8531315 · Received April 19, 2019

    Report

    Report Number
    2021898-2019-00155
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    January 1, 2018
    Report Date
    April 19, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADAM STRAND, STEPHEN BALISE, LAWRENCE JUN LEUNG, SUSAN DURHAM. "LOW-PRESSURE HYDROCEPHALUS: A CASE REPORT AND REVIEW OF THE LITERATURE." WORLD NEUROSURGERY 109 (2018). DOI: 10.1016/J.WNEU.2017.09.120. BACKGROUND: THE ENTITY OF LOW-PRESSURE HYDROCEPHALUS REMAINS POORLY UNDERSTOOD AND THOROUGHLY DEBATED. SYMPTOMATIC IMPROVEMENT ACCOMPANIED BY DECREASE IN VENTRICULAR SIZE AFTER PROLONGED SUBATMOSPHERIC DRAINAGE HAS BEEN WELL DOCUMENTED, AND THIS METHOD HAS BEEN CONSIDERED THE CRITERION STANDARD OF MANAGEMENT. FEW STUDIES HAVE EXAMINED ALTERNATIVE TREATMENT OPTIONS, EITHER TO AVOID THE RISKS ASSOCIATED WITH PROLONGED EXTERNAL VENTRICULAR DRAINAGE OR BECAUSE OF THE FAILURE OF TRADITIONAL METHODS. OBJECTIVES: THIS STUDY COMPILED AND EXAMINED REPORTED CASES OF LOW-PRESSURE HYDROCEPHALUS IN AN ATTEMPT TO PROVIDE AN UP-TO-DATE SUMMARY OF THE CONDITION. METHODS: A LITERATURE SEARCH WAS CONDUCTED BY USE OF OVID MEDLINE AND PUBMED FILTERED FOR THE PAST 25 YEARS WITH SPECIFIC KEY TERMS, INCLUSION CRITERIA, AND EXCLUSION CRITERIA. SELECTED CASE STUDIES AND CASE SERIES WERE THEN COMPARED, AND STATISTICAL ANALYSIS WAS PERFORMED WHERE APPROPRIATE. RESULTS: OVER 25 YEARS, 17 ARTICLES MET OUR CRITERIA. IN ADDITION TO OUR CASE, 90 CASES OF LPH WERE REPORTED. MAGNETIC RESONANCE ELASTOGRAPHY (MRE) HAS PROVED TO BE AN EFFECTIVE MEANS OF STUDYING THE VISCOELASTIC PROPERTIES OF THE BRAIN. ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) APPEARS TO BE A STRONG ALTERNATIVE, OR ADDITIONAL, TREATMENT. CONCLUSION: MRE MAY PROVE TO BE EFFECTIVE IN STUDYING LPH BECAUSE OF ITS ABILITY TO QUANTIFY VISCOELASTIC PROPERTIES IN RESPONSE TO THERAPY. ADDITIONALLY, ETV SHOULD BE CONSIDERED IN CASES OF LPH, ALTHOUGH THERE IS LITTLE EVIDENCE IN THE CURRENT LITERATURE TO SUPPORT ITS USE. THERE ARE SUGGESTIONS THAT IT MAY LEAD TO FEWER SHUNT DEPENDENT PATIENTS. FUTURE STUDIES ARE NEEDED BECAUSE THERE ARE FEW DOCUMENTED EXAMPLES. REPORTED EVENTS: A (B)(6) GIRL WAS ORIGINALLY BROUGHT FOR EXAMINATION AT THE AGE OF (B)(6) BECAUSE OF ATAXIA. SHE SUBSEQUENTLY UNDERWENT RESECTION OF A LARGE POSTERIOR FOSSA PILOCYTIC ASTROCYTOMA IN 2009. TWO WEEKS LATER, A VENTRICULOPERITONEAL SHUNT WAS PLACED WITH SIMULTANEOUS ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV). FOLLOW-UP IN 2013 REVEALED A CYSTIC NODULE ADJACENT TO THE TECTAL PLATE, WHICH WAS MONITORED CONSERVATIVELY FOR THE NEXT FEW YEARS. IN (B)(6) 2015, SHE WAS HOSPITALIZED FOR HEADACHES, AND CORRESPONDING VENTRICULOMEGALY WAS SHOWN ON MAGNETIC RESONANCE IMAGING (MRI). THE SHUNT WAS TAPPED AND ADJUSTED FROM 2.5 TO 0.5 WITH SYMPTOMATIC IMPROVEMENT. DURING THE NEXT MONTH, MULTIPLE ADJUSTMENTS LED TO A SHUNT REVISION, WITH A DELTA 2 VALVE REPLACING THE STRATA VALVE, PREVIOUSLY SET AT 2 FOR MANY YEARS. A DELTA 2 VALVE WAS SELECTED BECAUSE OF THE NEED FOR MULTIPLE MRIS IN THE FUTURE FOR SURVEILLANCE OF THE CYSTIC NODULE OF THE TECTAL PLATE AND NEED FOR REPROGRAMMING THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326031 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R