BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 3060040 · Received April 11, 2013

    Report

    Report Number
    2021898-2013-00137
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET REQUIREMENTS FOR THE SIPHON, REFLUX, PREIMPLANTATION, AND LEAKAGE TESTS. IT ALSO MET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTS. THEREFORE, THE CONDITIONS OF THE COMPLAINTS COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ADDITIONAL PATIENT/DEVICE INFORMATION: THE EXACT EVENT DATE/EXPLANT DATE IS UNKNOWN. ONLY THE MONTH AND YEAR ARE KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE PHYSICIAN ADJUSTED THE STRATA II VALVE TO PRESSURE LEVEL 2.0, THERE WAS EXCESSIVE DIVERSION AND WHEN THEY ADJUSTED THE VALVE TO PRESSURE LEVEL 2.5, THE PATIENT DEVELOPED A CEREBRAL HERNIA. THE PHYSICIAN BELIEVES THAT THERE MAY BE A LEAK FROM THE DEVICE, SO HE EXPLANTED THE ENTIRE SHUNT. IT WAS ALSO REPORTED THAT THE PATIENT IS UNDER RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156438 STRATA II VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D34389

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R