BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR RESERVOIR DOME ASSEMBLY WITH EXTENDED FLANGE

    MDR report key: 4233408 · Received November 6, 2014

    Report

    Report Number
    2021898-2014-00438
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K874498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETUNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ADDITIONAL PATIENT/DEVICE INFORMATION: IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD INTRAVENTRICULAR HEMORRHAGE IN THE OCCIPITAL HORN OF THE RIGHT SIDE, AND UNDERWENT REMOVAL OF THE RIGHT VENTRICULAR PERITONEAL SHUNT WITH REPLACEMENT OF A NEW VENTRICULAR SHUNT. ACCORDING TO THE REPORT, WHEN THE VALVE SHUNT WAS BROUGHT OUT FROM PREPERITONEAL CAVITY, VERY MINIMAL FLOW APPRECIATED. REPORTEDLY, THE VENTRICULAR CATHETER WAS REMOVED AND THE RIGHT FRONTAL HORN HAD ENTERED THE 7 CM CATHETER. THE REPORT STATED THAT THE FLOW WAS VERY LOW DUE TO VERY LOW COMPLIANCE OF THE BRAIN. ACCORDING TO THE REPORT, THE VALVE WAS CONNECTED TO THE SNAP CONNECTOR; HOWEVER, NO DISTAL FLOW APPRECIATED THROUGH, THEREFORE, THE DISTAL END OF VALVE WAS PULLED OUT. REPORTEDLY, THE VALVE WITH SIPHON REMOVED AND NEW VALVE WITHOUT SIPHON WAS PUT ON PRESSURE LEVEL 0.5. THE REPORT STATED THAT THE VALVE WAS THEN CONNECTED TO SNAP CONNECTOR AND THE VENTRICULAR CATHETER WITHOUT DIFFICULTY. ACCORDING TO THE REPORT, EXCELLENT FLOW TO THE DISTAL END WAS APPRECIATED. (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 THE PATIENT HAD UNDERGONE VP SHUNT PLACEMENT LATE IN THE SUMMER OF THIS YEAR. ACCORDING TO THE REPORT, THE PATIENT RETURNED TO THE ER A FEW DAYS LATER WITH A WORSENING ALTERED LEVEL OF CONSCIOUSNESS. THE REPORT STATED THAT A CT SCAN WAS PERFORMED WHICH SHOWED MODERATE TO SEVERE HYDROCEPHALUS WITH 13MM ROUND RIGHT FRONTAL LOBE HEMORRHAGE SURROUNDING CATHETER SITE. REPORTEDLY, THE PRESUMPTION WAS THAT THERE WAS A SHUNT MALFUNCTION CAUSING THE PATIENT'S ALTERED MENTAL STATUS. ACCORDING TO THE REPORT, DURING THEIR RETURN TRIP TO THE ER, THE PATIENT WAS REASSESSED BY NEUROSURGEON AND IT WAS DECIDED THAT THEY WOULD UNDERGO REMOVAL OF SHUNT AND REPLACEMENT WITH NEW VP SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712618 VENTRICULAR RESERVOIR DOME ASSEMBLY WITH EXTENDED FLANGE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D47854

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R