BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 2003630 · Received February 23, 2011

    Report

    Report Number
    2021898-2011-00043
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS PATENT, PASSED LEAK TESTING AND MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING AT 0 CM HYDROSTATIC PRESSURE. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR REFLUX OR SIPHON TESTING, WHICH PRECLUDED MEASURING OF PRESSURE-FLOW AT -50 CM HYDROSTATIC PRESSURE. CRYSTALLINE DEBRIS WAS FOUND ON THE EXTERIOR AND INTERIOR OF THE VALVE, PARTICULARLY ON THE DIAPHRAGMS OF 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. A DISSECTION OF THE ADJUSTMENT MECHANISM SHOWED NO ANOMALIES. IT IS UNK WHAT MAY HAVE CAUSED THE REPORTED LEVEL CHANGE. 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 THE 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 WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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 VALVE WAS CHANGING SETTINGS WITH NO OUTSIDE INTERFERENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R