BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA® NSC VALVE, REGULAR

    MDR report key: 4144016 · Received October 6, 2014

    Report

    Report Number
    2021898-2014-00395
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. THE VALVE MET THE REQUIREMENTS FOR SIPHON, REFLUX, PRESSURE-FLOW, PRE-IMPLANTATION, AND LEAK TESTING. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. THE VALVE WAS ABLE TO BE ADJUSTED TO ALL PERFORMANCE LEVELS WITHIN A SINGLE ATTEMPT AND THE PERFORMANCE LEVEL SETTINGS DID NOT SPONTANEOUSLY CHANGE DURING TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT SINCE THE STRATA WAS IMPLANTED IN 2010 THE VALVE'S PRESSURE-LEVEL SETTING HAS INADVERTENTLY CHANGED FROM TIME TO TIME. IN (B)(6) 2014, THE PATIENT CAME BACK TO (B)(6) WITH HEADACHES, NAUSEA AND VOMITING. THE PRESSURE WAS INITIALLY ADJUSTED TO 1.5. BEFORE SHE WAS RELEASED FROM THE HOSPITAL THE PRESSURE LEVEL SETTING WAS AT 0.5. IT WAS THEN RETURNED TO 1.5. SEVERAL DAYS LATER THE PATIENT CAME BACK AT PRESSURE-LEVEL 2.0. THE VALVE WAS EXPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622849 STRATA® NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| R