BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA MR SHUNT VALVE

    MDR report key: 6348661 · Received February 20, 2017

    Report

    Report Number
    MW5067984
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 20, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A STRATA MR VALVE INSERTED WITH A PRIMARY/HEW SHUNT INSERTION ON (B)(6) 2016. SHE REPRESENTED WITH SYMPTOMS OF SHUNT MALFUNCTION AND WAS REVISED ON (B)(6) 2017. WHEN PATIENT WAS EVALUATED INTRAOPERATIVELY, SHE WAS FOUND TO HAVE SLUGGISH/SLOW DRAINAGE WHEN ASSESSED WITH THE MANOMETER THROUGH THE VALVE ALTHOUGH SHE WAS SET AT A SHUNT VALVE SETTING OF 1.5. THE VALVE WAS NOTED TO ALSO HAVE LIMITED TO NO DRAINAGE THROUGH THE MANOMETER ONCE THE FLUID RAN DOWN TO A LEVEL OF ABOUT 25CM H20. THE VALVE WAS EXPLANTED AND REPLACED WITH A FIXED PRESSURE VALVE. DATES OF USE: (B)(6) 2016-(B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126518 STRATA MR SHUNT VALVE SHUNT JXG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Hospitalization| R