BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 7084687 · Received December 5, 2017

    Report

    Report Number
    2021898-2017-00628
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    September 25, 2016
    Report Date
    December 5, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169010796
    PMA / PMN Number
    K091312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PSEUDOTUMOR PATIENT WAS IMPLANTED IN (B)(6) 2016. ABOUT TWO WEEKS AFTER IMPLANT, THE PATIENT WAS DIZZY AND SICK. THEY WENT TO THE EMERGENCY ROOM WITH AN ELEVATED HEART RATE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH (B)(6). VANCOMYCIN WAS ADMINISTERED, AND THE SHUNT WAS EXPLANTED AT THE END OF (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863728 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44420 E05185 00643169010796

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R