BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA NSC VALVE/SHUNT

    MDR report key: 1504496 · Received October 2, 2009

    Report

    Report Number
    2021898-2009-00200
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    April 30, 2008
    Report Date
    September 4, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS IDENTIFIED DURING THE COURSE OF A RETROSPECTIVE CLINICAL STUDY, INVOLVING A REVIEW OF PT CASE RECORDS AND DATA ANALYSIS. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE AVAILABLE. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IN 2008, PT PRESENTED TO ER & ADMITTED DUE TO CONTINUED GAIT DISTURBANCE & A SHUNT STUDY WAS POSITIVE FOR SHUNT MALFUNCTION, DUE TO KINK/LOOP IN CATHETER. SIX DAYS LATER, EXPLANTED DUE TO LP SHUNT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA NSC VALVE/SHUNT 84JXG JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R