BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 6931510 · Received October 9, 2017

    Report

    Report Number
    2021898-2017-00509
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    October 9, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO REGULATORY REPORT # 2021898-2017-00508 FOR PREVIOUS HISTORY OF THE PATIENT. THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY.

    Description of Event or Problem · 1

    ALEX P. MICHAEL, AHMAD ELKOUZI, RODGER J. ELBLE. PEARLS <(>&<)> OY-STERS: LOW-PRESSURE HYDROCEPHALUS AND INADEQUATE SHUNTING. AMERICAN ACADEMY OF NEUROLOGY 88 (2017). CASE REPORT: A (B)(6) YEAR OLD FEMALE'S VP SHUNT WAS REVISED WITH AN ADJUSTABLE PS STRATA II VALVE (MEDTRONIC) PLACED ON THE LOWEST POSSIBLE RESISTANCE (PERFORMANCE LEVEL 0.5: OPENING PRESSURE 1.5 CM H2O SUPINE, 3 CM H2O STANDING). SHE CONTINUED TO RESULT IN DEPRESSED CONSCIOUSNESS UNLESS THE EXTERNAL VENTRICULAR DRAIN PRESS WAS,5 CMH2O. AFTER SEVERAL DAYS, THE EXTERNAL DRAIN WAS REMOVED, AND A VALVELESS VP SHUNT WAS PLACED TO ALLOW CONTINUOUS DRAINAGE. WITH THIS TREATMENT, SHE RECOVERED CONSCIOUSNESS AND WAS DISCHARGED HOME WITH NO NEUROLOGIC DEFICIT. HOWEVER, HER CHRONIC HEADACHES CONTINUED AS BEFORE, EVEN THOUGH CT SCANS 7 MONTHS, 2 YEARS, 3 YEARS, AND 5 YEARS LATER REVEALED NO HYDROCEPHALUS. FIVE YEARS AFTER PLACEMENT OF THE VALVELESS SHUNT, A FIBER OPTIC INTRAPARENCHYMAL MONITOR REVEALED NORMAL PRESSURES. HER CHRONIC HEADACHES PERSISTED AND WERE TREATED AS MIGRAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711210 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R