BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL VALVE, BUTTON

    MDR report key: 4849188 · Received June 16, 2015

    Report

    Report Number
    2021898-2015-00213
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 20, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K911410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR REFLUX, PRESSURE-FLOW, PREIMPLANTATION AND LEAK TESTING. THEREFORE THE CONDITION OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. SMALL AMOUNTS OF PROTEINACEOUS DEBRIS WERE NOTED WITHIN THE VALVE. THE INSTRUCTIONS FOR USE INDICATES THAT TO PERFORM THE PATENCY TEST: ATTACH A 16-GAUGE BLUNT NEEDLE AND SYRINGE TO THE VALVE INLET. FLUSH THE VALVE WITH STERILE, FILTERED, ISOTONIC SALINE. IF FLUID FLOWS OUT OF THE DISTAL CONNECTOR, THE VALVE IS PATENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ADDITIONAL PATIENT INFORMATION: IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SURGERY THE PATIENT UNDERWENT ON (B)(6) 2015 WAS A SHUNT REVISION. HOWEVER, IT IS UNKNOWN WHETHER THE SHUNT THAT WAS REVISED WAS A MEDTRONIC PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ADDITIONAL PATIENT INFORMATION: IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SURGERY THE PATIENT UNDERWENT ON 5/19/15 WAS A SHUNT REVISION. HOWEVER, IT IS UNKNOWN WHETHER THE SHUNT THAT WAS REVISED WAS A MEDTRONIC PRODUCT. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING SURGERY, A CSF-FLOW CONTROL VALVE WAS PLACED IN THE PATIENT AND NO FLOW WAS OB SERVED. REPORTEDLY, AFTER A SERIES OF TESTS, THE PHYSICIAN DETERMINED THAT THE VALVE WASN¿T ALLOWING ANY FLOW. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391811 CSF-FLOW CONTROL VALVE, BUTTON SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D10794

    Patients

    Seq Age Sex Outcome Treatment
    1