BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1870855 · Received October 7, 2010

    Report

    Report Number
    2021898-2010-00244
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS PATENT, PASSED LEAK AND REFLUX TESTING AND MET ALL SPECS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING AT 0 CM HYDROSTATIC PRESSURE. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR SIPHON TESTING, WHICH PRECLUDED MEASURING OF PRESSURE-FLOW AT -50 CM HYDROSTATIC PRESSURE. PROTEINACEOUS DEBRIS WAS FOUND ON THE INTERIOR OF THE VALVE, PARTICULARLY INSIDE THE DELTA CHAMBER. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE ANTI-SIPHON DEVICE, RESULTING IN SIPHONING. ALL PERFORMANCE LEVELS COULD BE SET WITH A SINGLE ATTEMPT, AND A LEVEL CHANGE COULD NOT BE INDUCED BY LABORATORY PERSONNEL WITHOUT USING A MAGNET. A DISSECTION OF THE ADJUSTMENT MECHANISM SHOWED NO ANOMALIES. STRATA PRODUCTS ARE DESIGNED TO BE ADJUSTED BY A STRONG MAGNET. INADVERTENT ADJUSTMENTS BY EXTERNAL MAGNETS ARE A KNOWN COMPLICATION WITH ADJUSTABLE VALVES. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE PRODUCT CAUTIONS THAT DEVICES KNOWN TO CONTAIN MAGNETS SHOULD BE KEPT AWAY FROM THE IMMEDIATE VALVE IMPLANT LOCATION, AS THEY MAY HAVE AN EFFECT ON THE PERFORMANCE LEVEL SETTING OF THE STRATA-TYPE VALVE. ALL MAGNETS HAVE AN EXPONENTIALLY DECREASING EFFECT ON THE VALVE THE FURTHER AWAY THEY ARE LOCATED. WHILE IT IS IMPOSSIBLE TO QUANTIFY ALL THE VARIOUS MAGNETIC FIELDS IN OUR ENVIRONMENT, THE VAST MAJORITY WILL NOT IMPACT THE VALVE AS LONG AS DISTANCE FROM THE VALVE IMPLANT IS MAINTAINED. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    THE PRESSURE LEVEL CHANGED FROM 1.5 TO 1.0 AND THEY CLAIM THAT THIS CHANGE IN SETTING HAPPENED WHEN THIS PT ENTERED OR LEFT A STORE WALKING THROUGH THE METAL DETECTOR. THE DEVICE WAS EXPLANTED AND REPLACED WITH A FIXED PRESSURE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA 46751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R