BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, SMALL

    MDR report key: 3050357 · Received April 8, 2013

    Report

    Report Number
    2021898-2013-00130
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN PERFORMED PREIMPLANTATION TESTING ON THE DEVICE AND THAT THE PRODUCT PERFORMED AS SPECIFIED IN THE DEVICE INSTRUCTIONS FOR USE. ACCORDING TO THE REPORT, UPON CONNECTING THE VALVE AND CATHETERS THERE WAS NO DRAINAGE FROM THE DISTAL CATHETER. THE REPORT STATES THAT ANOTHER VISUAL TEST TO THE SYSTEM WAS THEN PERFORMED, AND THAT A LEAK WAS FOUND AT THE TOP OF THE DELTA CHAMBER. NO ADVERSE IMPACT OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144238 STRATA II VALVE, SMALL JXG MEDTRONIC NEUROSURGERY D34071

    Patients

    Seq Age Sex Outcome Treatment
    1