BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC LUMBAR PERITONEAL SHUNT VALVE

    MDR report key: 3131452 · Received May 28, 2013

    Report

    Report Number
    3131452
    Date Received
    May 28, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED TO RISK MANAGEMENT THAT A PATIENT WAS BROUGHT TO THE OPERATING ROOM DUE TO A MEDTRONIC LP SHUNT MALFUNCTION. IN REVIEWING RECORDS FOUND THE FOLLOWING INFORMATION. THE (B)(6) HAS THAT THIS PATIENT HAD AN LP SHUNT PLACED ON (B)(6) 2012. SINCE THAT TIME THE DEVICE HAS RESET ITSELF 4 TIMES. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2013 AND THE LP SHUNT SETTING WAS FOUND TO BE AT 2.5. THE TIME BEFORE THIS VISIT ON (B)(6) 2012 THE DEVICE HAD BEEN SET BETWEEN 1 -1.5. ON THE (B)(6) 2013 VISIT THE PATIENT HAD BEEN COMPLAINING OF INCREASE IN HEADACHES AND CHANGE IN VISION. THE SURGEON DISCUSSED WITH THE PATIENT OPTIONS AND IT WAS DECIDED TO RETURN TO SURGERY TO REPLACE THE MALFUNCTIONING VALVE. THE PATIENT CAME TO THE HOSPITAL (B)(6) 2013 TO HAVE THE VALVE REPLACED. DURING THE SURGERY IT WAS DISCOVERED THAT THE "PROXIMAL CATHETER WAS KINKED RIGHT AT THE INTAKE AREA OF THE VALVE." THE MEDTRONIC REPRESENTATIVE WAS PRESENT IN SURGERY THE DAY OF SURGERY BUT THE DEVICE WAS SEQUESTERED FOR RISK. WILL REACH OUT TO (B)(6) SO THAT HE MAY PICK UP THE DEVICE. THE PATIENT WENT HOME THE SAME DAY OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233225 MEDTRONIC LUMBAR PERITONEAL SHUNT VALVE LP SHUNT JXG MEDTRONIC, INC. D17326

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization