BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 2802566 · Received October 19, 2012

    Report

    Report Number
    2021898-2012-00319
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303A
    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 DRAINAGE BAG WAS RETURNED TO THE MFR. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE VERIFIED AND AN EVAL OF THE CATHETER 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. NO IMPACT OR INJURY TO THE PT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A LUMBAR CATHETER OF AN EDM EXTERNAL DRAINAGE KIT WAS FOUND TO BE LEAKING.

    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 12207998

    Patients

    Seq Age Sex Outcome Treatment
    1