BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, REGULAR, INTEGRAL SNAP

    MDR report key: 1001647 · Received February 18, 2008

    Report

    Report Number
    2021898-2008-00044
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 25, 2008
    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 RETURNED VALVE WAS NOT PATENT DUE TO A LARGE JAGGED TEAR IN THE TOP OF THE RESERVOIR. THIS DAMAGE PRECLUDED ALL FURTHER TESTING. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR PRODUCTS ARE 100% TESTED AT THE TIME OF MFR. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE VALVES CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE HAD A HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, REGULAR, INTEGRAL SNAP 84JXG JXG MEDTRONIC NEUROSURGERY NA A91960

    Patients

    Seq Age Sex Outcome Treatment
    1