BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC STRATAMR VALVE AND SHUBT

    MDR report key: 7247353 · Received February 6, 2018

    Report

    Report Number
    MW5075095
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    January 18, 2018
    Report Date
    February 5, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 (B)(6) BEGAN EXPERIENCING HEADACHE, DIZZINESS, AND THE FEELING HIS SURROUNDINGS WERE SPINNING. HE HAS A SHUNT TO DRAIN CEREBROSPINAL FLUID, THE MOST RECENT IMPLANTED (B)(6) 2017. SINCE HE USES A WHEELCHAIR HE WAS UNABLE TO SAFELY GET OUT OF BED. DR. (B)(6) OFFICE WAS CONTACTED THURSDAY MORNING AND AGAIN ON FRIDAY. HE WAS TOLD HE WOULD NEED TO WAIT UNTIL MONDAY TO DETERMINE WHEN THE TOOL NEEDED TO CHECK HIS SHUNT WOULD BE AVAILABLE. MONDAY AN APPOINTMENT WAS SCHEDULED. DR. (B)(6) NURSE AND A MEDTRONIC TECHNICIAN CHECK THE SHUNT CALIBRATION AND DETERMINED IT WAS SET ON ONE WHEN IT SHOULD HAVE BEEN TWO. THE SHUNT WAS RESET TO 2. NO EXPLANATION WAS DETERMINED FOR WHY THE SETTING CHANGED. (B)(6) REMAINED IN BED FLAT ON HIS BACK FROM THURSDAY UNTIL THE APPOINTMENT ON MONDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89360 MEDTRONIC STRATAMR VALVE AND SHUBT SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention