BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 7060875 · Received November 27, 2017

    Report

    Report Number
    2021898-2017-00593
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 1, 2017
    Report Date
    November 27, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THAT WHEN THE LUMBAR PERITIONEAL (LP) SHUNT PROCEDURE WAS PERFORMED IN THE 4TH WEEK OF (B)(6) 2017, A LUMBAR CATHETER COULD NOT BE INSERTED SMOOTHLY. THEN, THE LUMBAR CATHETER WAS MISTAKENLY PULLED OUT IN THE OPPOSITE DIRECTION WHILE THE PUNCTURE NEEDLE HAD BEEN INSERTED. AS A RESULT, THE TIP OF THE LUMBAR CATHETER WAS SCOOPED OUT, AND THE DETACHED FRAGMENTS HAVE BEEN DRIFTING IN THE SPINAL CAVITY. IT WAS NOTED THAT THE TIP OF THE LUMBAR CATHETER WAS DETACHED AS IT WAS SCOOPED OUT BY THE PUNCTURE NEEDLE. WHILE SOME FRAGMENTS WERE REMOVED OUT OF THE PATIENT'S BODY, SOME HAVE BEEN DRIFTING IN THE SPINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838599 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44421 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1