BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 8550837 · Received April 24, 2019

    Report

    Report Number
    MW5086167
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    February 2, 2019
    Report Date
    April 15, 2019
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MRI. THE PROGRAMMABLE SHUNT IS CONDITIONAL TO 1.5 TESLA WITH PRESSURE SETTING TO BE CHECKED BEFORE AND AFTER MRI EXPOSURE PER MANUFACTURER WEBSITE. FSH MRI GUIDELINES INDICATE IF PATIENT DOESN'T HAVE A APPOINTMENT WITH NEUROLOGIST TO CHECK. SHUNT WITHIN 24 HOURS AFTER MRI, STAFF SHOULD OBTAIN XRAY SHUNT SERIES PRE AND POST MRI. PATIENT HAD A MRI ABDOMEN WITH PROGRAMMABLE VP SHUNT. SHUNT WAS DISCLOSED ON METAL SAFETY CHECKLIST. DURING A HAND OFF OF CARE, SHUNT WAS DESCRIBED TO SCANNING TECH AS SAFE, WHEN IN FACT THE SHUNT WAS PROGRAMMABLE. WITHOUT THIS OCCURRING, PATIENT SLOWLY DEVELOPED HYDROCEPHALUS, PER UNIVERSITY NEUROLOGIST. DISCOVERY OF SHUNT PRESSURE SETTING MODIFICATIONS, DUE TO MRI ENVIRONMENT, WAS NOT UNTIL ONE MONTH AFTER PATIENT WAS DISCHARGED FROM HOSPITAL ORIGINAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339866 POLARIS ADJUSTABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG SOPHYSA SA SPV-140 A0711

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization