BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATA, ADJUSTABLE DELTA UNITIZED SHUNT

    MDR report key: 478135 · Received August 11, 2003

    Report

    Report Number
    2021898-2003-00114
    Event Type
    Other
    Date Received
    August 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT SUFFERED SHUNT MALFUNCTION. THE PHYSICIAN SAMPLED THE CSF FROM THE RESERVOIR AND FOUND THAT IT WAS COLORED RED. THE CATHETER WAS REVISED. SOME DEBRIS AT THE END OF THE VENTRICLE CATHETER WERE FOUND. THE DOCTOR WAS NOT CERTAIN IF THE PROBLEM WAS PRODUCT RELATED OR IF THE DEBRIS WERE FROM SHUNT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA, ADJUSTABLE DELTA UNITIZED SHUNT CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC NEUROSURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN