BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 ADJUSTABLE VALVE, REGULAR

    MDR report key: 1870854 · Received October 7, 2010

    Report

    Report Number
    2021898-2010-00243
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT, PASSED REFLUX TESTING AND MET ALL SPECS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING AT 0 CM HYDROSTATIC PRESSURE. THE VALVE DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A SMALL TEAR IN THE TOP OF THE DELTA CHAMBER. THE VALVE ALSO DID NOT MEET THE REQUIREMENTS FOR SIPHON TESTING, WHICH PRECLUDED PRESSURE-FLOW TESTING AT -50 CM HYDROSTATIC PRESSURE. VALVE DISSECTION SHOWED THAT THE SIPHON CONTROL BASE WAS DAMAGED BELOW THE DIAPHRAGM OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THESE DAMAGES OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "IMPROPER USE OF INSTRUMENTS IN THE HANDLING OR IMPLANTATION OF SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. SUCH DAMAGE MAY LEAD TO LOSS OF SHUNT INTEGRITY, AND NECESSITATE PREMATURE SURGICAL REVISION OF THE SHUNT SYSTEM." 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. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFG.

    Description of Event or Problem · 1

    THIS PT HAD A STRATA II VPS SET TO 1.5 INSERTED IN (B)(6) 2009 FOR HA/.HYDROCEPHALUS SECONDARY TO LIKELY SUBCLINICAL AQUEDUCT STENOSIS. THIS TEMPORARILY RELIEVED HIS HA'S FOR A FEW MONTHS, WHICH RECURRED IN (B)(6) 2010. ON REVIEW IN (B)(6) CTB WAS UNCHANGED HOWEVER THE SETTING HAD CHANGED TO 2.0. IT WAS CHANGED BACK TO 1.5, HOWEVER HE REPRESENTED TO WITH INCREASING HA AND ON REPEAT SCAN WAS SHOWN TO HAVE MODERATE SIZED BILATERAL SUBACUTE/CHRONIC SUBDURALS. ON CHECKING HIS SETTING IT HAD AGAIN CHANGED TO 2.0. CLINICALLY, THE SHUNT APPEARED TO WORK WELL, EASILY COMPRESSIBLE AND QUICK TO REFILL. BILATERAL BURRHOLES WERE PERFORMED AND THE VALVE WAS CHANGED LAST WEEK. THE VENTRICULAR CATHETER WAS FLOWING FREELY AND THE DISTAL TUBING FLUSHED FREELY. THE PT IS MAKING AN UNEVENTFUL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C43192

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R