BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 2

    MDR report key: 485108 · Received September 19, 2003

    Report

    Report Number
    2021898-2003-00138
    Event Type
    Other
    Date Received
    September 19, 2003
    Date of Event
    June 27, 2003
    Report Date
    September 5, 2003
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VALVE DID NOT PASS PRE-IMPLANTATION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 2 CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC NEUROSURGERY * T6745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN