BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTEGRA NPH LOW FLOW VALVE

    MDR report key: 2195131 · Received July 14, 2011

    Report

    Report Number
    9612007-2011-00027
    Event Type
    Other
    Date Received
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IN JUNE (UNK YEAR), THE PT HAD A "SAB HUNT & HESS DEGREE IV" FROM AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE PT HAD AN EMBOLISM. IT WAS REPORTED THAT THE PT WAS "OKAY" AFTER THAT. THEN, ON (B)(6) 2010, THE PT HAD POST HEMORRHAGIC HYDROCEPHALUS AND THE FIRST SHUNT (GAV 5/30-VENTIL) WAS IMPLANTED. DUE TO A SHUNT DYSFUNCTION, THE GAV 5/30-VENTIL WAS EXPLANTED AND ANOTHER VALVE (INTEGRA NPH LOW FLOW VALVE: (B)(4)) ALONG WITH A RICKHAM RESERVOIR WERE IMPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE CLINICAL DEVELOPMENT OF THE PT HAD BECOME SIGNIFICANTLY WORSE AFTER THIS IMPLANTATION. IT WAS REPORTED THAT THE SURGEON HAD A SUSPICION OF VALVE DYSFUNCTION BECAUSE THERE WERE SEVERAL THERAPEUTIC PUNCTURES OF THE RICKHAM RESERVOIR. AFTER THESE PUNCTURES, THE PT'S HEADACHES DISAPPEARED. THE PT WAS MORE DYNAMIC AND HIS GAIT WAS MORE FLUID AFTER THE PUNCTURES. HENCE, THE SURGEON DECIDED TO REPLACE THE INTEGRA NPH LOW FLOW VALVE WITH THE HAKIM-MEDOS-VALVE WITH A PRESSURE LEVEL OF 100 MMHG ON (B)(6) 2011. THERE WAS PT IMPROVEMENT AFTER THE SURGERY. THE PT FELT BETTER, HAD LESS HEADACHES, AND THE PT WALKED WITH MORE EASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA NPH LOW FLOW VALVE NPH LOW FLOW VALVE JXG INTEGRA, BIOT 0157962

    Patients

    Seq Age Sex Outcome Treatment
    1