BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-LUMBOPERITONEAL CATHETER SYSTEM

    MDR report key: 3950571 · Received July 22, 2014

    Report

    Report Number
    2021898-2014-00259
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTIONS THAT TO AVOID POSSIBLE TRANSECTION OF THE CATHETER, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE AND CATHETER (WITH GUIDEWIRE, IF USED) MUST BE REMOVED SIMULTANEOUSLY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN EXPERIENCED DIFFICULTY IN PLACING THE DEVICE DURING THE PROCEDURE, AND THAT AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS THE CATHETER BROKE. THE REPORT STATES THAT THE CATHETER HAD BEEN WITHDRAWN THROUGH THE TUOHY NEEDLE AFTER EACH UNSUCCESSFUL ATTEMPT. ACCORDING TO THE REPORT, A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. THE REPORT STATES THAT THE PATIENT DID NOT INCUR ANY INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427558 CSF-LUMBOPERITONEAL CATHETER SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D12288

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR