BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 7007690 · Received November 7, 2017

    Report

    Report Number
    2021898-2017-00562
    Event Type
    Injury
    Date Received
    November 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED IS NOTED IN EACH EVENT AS KNOWN. THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THOMAS PENNELL, JUNEYOUNG L. YI, BRUCE A. KAUFMAN, SATISH KRISHNAMURTHY. NONINVASIVE MEASUREMENT OF CEREBROSPINAL FLUID FLOW USING AN ULTRASONIC TRANSIT TIME FLOW SENSOR: A PRELIMINARY STUDY. JOURNAL OF NEUROSURGERY PEDIATRICS 17 (2016). DOI: 10.3171/2015.7.PEDS1577 OBJECTIVE MECHANICAL FAILURE¿WHICH IS THE PRIMARY CAUSE OF CSF SHUNT MALFUNCTION¿IS NOT READILY DIAGNOSED, AND THE SPECIFIC REASONS FOR MECHANICAL FAILURE ARE NOT EASILY DISCERNED. PRIOR ATTEMPTS TO MEASURE CSF FLOW NONINVASIVELY HAVE LACKED THE ABILITY TO EITHER QUANTITATIVELY OR QUALITATIVELY OBTAIN DATA. TO ADDRESS THESE NEEDS, THIS PRELIMINARY STUDY EVALUATES AN ULTRASONIC TRANSIT TIME FLOW SENSOR IN PEDIATRIC AND ADULT PATIENTS WITH EXTERNAL VENTRICULAR DRAINS (EVDS). ONE GOAL WAS TO CONFIRM THE STATED ACCURACY OF THE SENSOR IN A CLINICAL SETTING. A SECOND GOAL WAS TO OBSERVE THE SENSOR¿S CAPABILITY TO RECORD REAL-TIME CONTINUOUS CSF FLOW. THE FINAL GOAL WAS TO OBSERVE RECORDINGS DURING INSTANCES OF FLOW BLOCKAGE OR LACK OF FLOW IN ORDER TO DETERMINE THE SENSOR¿S ABILITY TO IDENTIFY THESE CHANGES. METHODS A TOTAL OF 5 PEDIATRIC AND 11 ADULT PATIENTS WHO HAD RECEIVED EVDS FOR THE TREATMENT OF HYDROCEPHALUS WERE STUDIED IN A HOSPITAL SETTING. THE PRIMARY EVD WAS CONNECTED TO A SECONDARY STUDY EVD THAT CONTAINED A FLUID-FILLED PRESSURE TRANSDUCER AND AN IN-LINE TRANSIT TIME FLOW SENSOR. COMPARISONS WERE MADE BETWEEN THE WEIGHT OF THE DRAINAGE BAG AND THE FLOW MEASURED VIA THE SENSOR IN ORDER TO CONFIRM ITS ACCURACY. DATA FROM THE PRESSURE TRANSDUCER AND THE FLOW SENSOR WERE RECORDED CONTINUOUSLY AT 100 HZ FOR A PERIOD OF 24 HOURS BY A DATA ACQUISITION SYSTEM, WHILE THE HOURLY CSF FLOW INTO THE DRIP CHAMBER WAS RECORDED MANUALLY. CHANGES IN THE PATIENT¿S NEUROLOGICAL STATUS AND THEIR TIME POINTS WERE NOTED. RESULTS THE FLOW SENSOR DEMONSTRATED A PROVEN ACCURACY OF ± 15% OR ± 2 ML/HR. THE FLOW SENSOR ALLOWED REAL-TIME CONTINUOUS FLOW WAVEFORM DATA RECORDINGS. DYNAMIC ANALYSIS OF CSF FLOW WAVEFORMS ALLOWED THE CALCULATION OF THE PRESSURE-VOLUME INDEX. LASTLY, THE SENSOR WAS ABLE TO DIAGNOSE A BLOCKED CATHETER AND DISTINGUISH BETWEEN THE BLOCKAGE AND LACK OF FLOW. CONCLUSIONS THE TRANSONIC FLOW SENSOR ACCURATELY MEASURES CSF OUTPUT WITHIN ± 15% OR ± 2 ML/HR, DIAGNOSES THE BLOCKAGE OR LACK OF FLOW, AND RECORDS REAL-TIME CONTINUOUS FLOW DATA IN PATIENTS WITH EVDS. CALCULATIONS OF A WIDE VARIETY OF DIAGNOSTIC PARAMETERS CAN BE MADE FROM THE WAVEFORM RECORDINGS, INCLUDING RESISTANCE AND COMPLIANCE OF THE VENTRICULAR CATHETERS AND THE COMPLIANCE OF THE BRAIN. THE SENSOR¿S CLINICAL APPLICATIONS MAY BE OF PARTICULAR IMPORTANCE TO THE NONINVASIVE DIAGNOSIS OF SHUNT MALFUNCTIONS WITH THE DEVELOPMENT OF AN IMPLANTABLE DEVICE. REPORTED EVENTS: A 10 YEAR OLD MALE EXPERIENCED A SHUNT INFECTION, AND THE PATIENT RECEIVED AN EVD. A (B)(6) YEAR OLD FEMALE EXPERIENCED A SHUNT INFECTION, AND THE PATIENT RECEIVED AN EVD. A (B)(6) YEAR OLD MALE EXPERIENCED A SHUNT INFECTION, AND THE PATIENT RECEIVED AN EVD. A (B)(6)-YEAR-OLD, (B)(6) MALE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL FOR VENTRICULOPERITONEAL SHUNT MALFUNCTION DUE TO POOR ABDOMINAL ABSORPTION. THE SHUNT WAS REMOVED, AND THE PATIENT RECEIVED AN EVD WHILE AWAITING THE IMPLANTATION OF A NEW SHUNT SYSTEM. THE PATIENT COMPLAINED OF A HEADACHE AT APPROXIMATELY 4.75 HOURS AFTER THE START OF THE STUDY. PHYSICAL EXAMINATION REVEALED THAT THE SHUNT CATHETER HAD BECOME KINKED AT ITS EXIT POINT. THE CATHETER WAS UNKINKED AND THEN SUTURED TO THE SCALP TO PREVENT RE-KINKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785536 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R