BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM

    MDR report key: 7259720 · Received February 9, 2018

    Report

    Report Number
    2021898-2018-00078
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 5, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE REPORT NUMBER 2021898-2018-00077. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH CATHETERS "SPLIT' DURING AN ATTEMPTED INSERTION. IT WAS CONFIRMED THAT THE 3RD CATHETER WAS INSERTED SUCCESSFULLY AFTER A 3 MINUTE DELAY AND THE PROCEDURE PROCEEDED AS PLANNED. THERE WAS NO STAFF OR PATIENT IMPACT. PLEASE SEE REPORT NUMBER 2021898-2018-00077.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THERE WERE NO EXTERNAL FACTORS THAT THE HEALTH CARE PROVIDER (HCP) WAS AWARE OF WHEN THE EVENT OCCURRED. THE HCP USED THE PRODUCT MANY TIMES BEFORE AND REPORTED THAT THE CATHETER "JUST SPLIT OPEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104723 EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 46419 212551238

    Patients

    Seq Age Sex Outcome Treatment
    1