BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 2831653 · Received November 9, 2012

    Report

    Report Number
    2021898-2012-00372
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT DESCRIBED LEAKAGE OF THE EDM CATHETER, HOWEVER, ONLY A STOPCOCK WAS RETURNED TO THE MANUFACTURER. THE CATHETER INVOLVED IN THE REPORTED EVENT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF 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. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER IMPLANTATION, THE LUMBAR CATHETER WAS FOUND TO BE LEAKING. ACCORDING TO THE REPORT, THE CATHETER WAS REPLACED AND THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 12277427

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R