BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC SOFAMOR DANEK

    MDR report key: 538771 · Received August 12, 2004

    Report

    Report Number
    538771
    Event Type
    Other
    Date Received
    August 12, 2004
    Date of Event
    July 6, 2004
    Report Date
    August 11, 2004
    Manufacturer
    MEDTRONICS
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING VP SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOFAMOR DANEK SNAP SHUNT CATHETER STANDARD 6CM JXG MEDTRONICS * A34668
    2 MEDTRONIC SOFAMOR DANEK STRATA SNAP SHUNT ASSEMBLY 120 CM REGULAR JXG MEDTRONICS * A28633

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other