BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPHYSA POLARIS

    MDR report key: 6685754 · Received July 5, 2017

    Report

    Report Number
    6685754
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 16, 2017
    Manufacturer
    SOPHYSA USA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BRAND NAME: FOR TYPE OF DEVICE: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS DO YOU INTEND TO RETURN THE DEVICE TO THE MANUFACTURER IN THE NEAR FUTURE? FOR TYPE OF DEVICE: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS DEVICE LOT #: FOR TYPE OF DEVICE: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS WHERE IS THE DEVICE NOW? FOR TYPE OF DEVICE: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS.

    Description of Event or Problem · 1

    EXCERPT FROM OP NOTE: "HAD A VP SHUNT PLACED MANY YEARS AGO FOR ACUTE OBSTRUCTIVE HYDROCEPHALUS. THIS WORKED WELL UNTIL A FEW MONTHS AGO WHEN SHE STARTED DEVELOPING INCREASING HEADACHES AND VISUAL DISTURBANCES INCLUDING DIPLOPIA... THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE SHUNT WAS REVISED WITH THE ENTIRE PLACEMENT OF AN ENTIRE NEW DISTAL SYSTEM AND VALVE. THE VENTRICULAR CATHETER WORKED WELL. THE PATIENT THEN PRESENTED BACK ON SEVERAL OCCASIONS WITH PROBLEMS WITH THE SHUNT. THE SHUNT WORKED WELL FOR A COUPLE OF WEEKS, THEN SHE STARTED DEVELOPING WHAT SHE THOUGHT WERE LOW PRESSURE HEADACHES...THERE WAS A SMALL CURVE OF THE DISTAL CATHETER JUST CAUDAL TO THE ANTI-SIPHON DEVICE. I THOUGHT THIS COULD BE CAUSING THE PROBLEM, SO SHE WAS SENT UP FOR SHUNT REVISION TODAY. THIS DID NOT APPEAR TO BE CAUSING THE PROBLEM, THE PROBLEM APPEARS TO BE IN THE VALVE SYSTEM... THE VENTRICULAR CATHETER WAS IDENTIFIED AND CUT JUST PROXIMAL TO THE SHUNT. BRISK EGRESS OF SPINAL FLUID CAME OUT OF THE VENTRICULAR CATHETER WITHOUT ANY EVENT. THIS WAS PERFECTLY CLEAR AND UNDER RELATIVELY HIGH PRESSURE. A RUBBER SHOD WAS PLACED IMMEDIATELY. THIS INDICATES WITHOUT QUESTION THAT THE FAILURE IS SOMEWHERE WITHIN THE SYSTEM OF THE VALVE AND ANTI-SIPHON DEVICE.

    Description of Event or Problem · 1

    EXCERPT FROM OP NOTE:"HAD A VP SHUNT PLACED MANY YEARS AGO FOR ACUTE OBSTRUCTIVE HYDROCEPHALUS. THIS WORKED WELL UNTIL A FEW MONTHS AGO WHEN SHE STARTED DEVELOPING INCREASING HEADACHES AND VISUAL DISTURBANCES INCLUDING DIPLOPIA... THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE SHUNT WAS REVISED WITH THE ENTIRE PLACEMENT OF AN ENTIRE NEW DISTAL SYSTEM AND VALVE. THE VENTRICULAR CATHETER WORKED WELL. THE PATIENT THEN PRESENTED BACK ON SEVERAL OCCASIONS WITH PROBLEMS WITH THE SHUNT. THE SHUNT WORKED WELL FOR A COUPLE OF WEEKS, THEN SHE STARTED DEVELOPING WHAT SHE THOUGHT WERE LOW PRESSURE HEADACHES...THERE WAS A SMALL CURVE OF THE DISTAL CATHETER JUST CAUDAL TO THE ANTI-SIPHON DEVICE. I THOUGHT THIS COULD BE CAUSING THE PROBLEM, SO SHE WAS SENT UP FOR SHUNT REVISION TODAY. THIS DID NOT APPEAR TO BE CAUSING THE PROBLEM, THE PROBLEM APPEARS TO BE IN THE VALVE SYSTEM... THE VENTRICULAR CATHETER WAS IDENTIFIED AND CUT JUST PROXIMAL TO THE SHUNT. BRISK EGRESS OF SPINAL FLUID CAME OUT OF THE VENTRICULAR CATHETER WITHOUT ANY EVENT. THIS WAS PERFECTLY CLEAR AND UNDER RELATIVELY HIGH PRESSURE. A RUBBER SHOD WAS PLACED IMMEDIATELY. THIS INDICATES WITHOUT QUESTION THAT THE FAILURE IS SOMEWHERE WITHIN THE SYSTEM OF THE VALVE AND ANTI-SIPHON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467075 SOPHYSA POLARIS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG SOPHYSA USA SPVA-SX 0212200917

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R