BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATA, ADJUSTABLE DELTA VALVE, REGULAR

    MDR report key: 475934 · Received July 31, 2003

    Report

    Report Number
    2021898-2003-00106
    Event Type
    Other
    Date Received
    July 31, 2003
    Report Date
    July 1, 2003
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS NOT FILLING PROPERLY CAUSING A POSSIBLE HEMATOMA. IT IS SUSPECTED BY THE DOCTOR THAT THE CAUSE OF THE PROBLEM MAY BE OCCLUSION IN THE VALVE OR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA, ADJUSTABLE DELTA VALVE, REGULAR CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC NEUROSURGERY * A17103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN