BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM VENTRICULAR CATHETER, TRANSLUCENT

    MDR report key: 2935003 · Received January 25, 2013

    Report

    Report Number
    2021898-2013-00024
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. 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 DURING PREIMPLANTATION THE DEVICES FUNCTIONED APPROPRIATELY. THE REPORT THEN STATES THAT FOLLOWING PLACEMENT OF THE CATHETER IN THE PATIENT, A LEAK WAS FOUND WHERE IT CONNECTED TO THE DRAINAGE SYSTEM. ACCORDING TO THE REPORT, NEW DEVICES WERE THEN OBTAINED AND USED TO COMPLETE THE PROCEDURE WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36220 EDM VENTRICULAR CATHETER, TRANSLUCENT JXG MEDTRONIC NEUROSURGERY D22163

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR