BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 7683757 · Received July 12, 2018

    Report

    Report Number
    2021898-2018-00344
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    January 1, 2009
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED ON AN ONLINE FORUM AND PROVIDED TO THE MANUFACTURER BY A SEPARATE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE COUNTRY THE EVENT OCCURRED IN IS UNKNOWN. EVENT AND IMPLANT DATES ARE APPROXIMATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED SINCE 2009 AND HAD BEEN EXPERIENCING HEADACHES. REPORTEDLY, EACH TIME THE PATIENT WOULD GET A CT SCAN, IT WAS FOUND THAT THEIR VENTRICLES WERE ENLARGED. IT WAS STATED THAT NO ADJUSTMENTS OR CHECKS WERE MADE. IN ADDITION TO HEADACHES, THE PATIENT¿S BALANCE WAS OFF, AND THEY HAD BLURRED VISION. THE PATIENT HAD ¿JUST ABOUT 20 OR SO¿ SURGERIES ON THEIR HEAD; IN ¿2001, 15 TIMES¿ AND IN 2009 ¿HAD TO REVISE IT APPROXIMATELY 5 TIMES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526193 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R