BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NEUROSURGERY

    MDR report key: 2875894 · Received December 13, 2012

    Report

    Report Number
    2021898-2012-00423
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS. CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS OR TEARS. THE INSTRUCTION FOR USE ALSO CAUTION THAT THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TOUHY NEEDLE IN ORDER TO AVOID POSSIBLE TRANSECTION OF THE CATHETER. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TOUHY NEEDLE AND CATHETER (WITH GUIDEWIRE IF USED) MUST BE REMOVED SIMULTANEOUSLY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHILE INSERTING THE LUMBAR CATHETER BETWEEN THE L3-L4 VERTEBRAE, THE PHYSICIAN ENCOUNTERED DIFFICULTY AND WAS UNABLE TO CONFIDENTLY PLACE THE DEVICE INTO IT'S PROPER POSITIONING. ACCORDING TO THE REPORT, THE PHYSICIAN WITHDRAW THE CATHETER THROUGH THE LUMBAR NEEDLE IN AN ATTEMPT TO REPOSITION THE DEVICE. THE REPORT STATES THAT UPON REMOVAL OF THE CATHETER FROM THE NEEDLE, IT WAS FOUND THAT A PORTION OF THE CATHETER'S PROXIMAL TIP HAD BROKEN OFF AND REMAINED IN THE PATIENT. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP, BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC NEUROSURGERY JXG-SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11655822

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR