BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 8188414 · Received December 21, 2018

    Report

    Report Number
    2021898-2018-00580
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    December 20, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    MICHAEL KIM, ILYA RYBKIN, HARRISON SMITH, JARED COOPER, MICHAEL TOBIAS. BONE OVERGROWTH CAUSING PROXIMAL VENTRICULOPERITONEAL SHUNT MALFUNCTION. WORLD NEUROSURGERY 121 (2019). DOI: 10.1016/J.WNEU.2018.10.030. BACKGROUND: HYDROCEPHALUS IS AN INTERNATIONAL DISEASE PROCESS THAT IS COMMONLY TREATED SURGICALLY WITH A VENTRICULOPERITONEAL SHUNT. THIS DEVICE MAY BE PRONE TO MALFUNCTION, MOST COMMONLY FROM OBSTRUCTION, DISCONNECTION, OR INFECTION. CASE DESCRIPTION: A (B)(6) YEAR-OLD FEMALE WITH HYDROCEPHALUS AND A VENTRICULOPERITONEAL SHUNT PRESENTED WITH ALTERED MENTAL STATUS AND IMAGING CONCERNING FOR A SHUNT MALFUNCTION. INTRAOPERATIVELY, SHE WAS FOUND TO HAVE BONE GROWING OVER AND COMPRESSING THE PROXIMAL OCCLUDER OF THE SHUNT VALVE, CAUSING A MECHANICAL OBSTRUCTION. REMOVAL OF THE BONE ALLOWED FOR EGRESS OF CEREBROSPINAL FLUID AND RETURN OF PROPER SHUNT FUNCTION. THE PATIENT DID WELL POSTOPERATIVELY. CONCLUSION: HYDROCEPHALUS, VENTRICULOPERITONEAL SHUNTS, AND SHUNT REVISIONS REPRESENT A SIGNIFICANT HEALTH BURDEN AND COST. HERE WE PRESENT AN UNUSUAL CAUSE OF A SHUNT MALFUNCTION CAUSED BY BONY OVERGROWTH. REPORTED EVENTS. THE (B)(6) YEAR OLD FEMALE HAD ONE PRIOR REVISION OF THEIR VPS 8 YEARS PRIOR DUE TO FRACTURING OF THE DISTAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028072 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R