BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDM CATHETER

    MDR report key: 5955098 · Received September 15, 2016

    Report

    Report Number
    2021898-2016-00333
    Event Type
    Injury
    Date Received
    September 15, 2016
    Report Date
    August 16, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. LITERATURE ARTICLE: COMPARISON OF CONTINUOUS LUMBAR DRAINAGE WITH CATHETERS IN DIFFERENT DIRECTIONS SUN T, ZANG SJ, JIANG ZQ, ZHENG XL, ZHANG T CHINA JOURNAL OF MODERN MEDICINE (2015) 25(27):96-98 DOI: 1005-8982(2015)27-0096-03.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: A TOTAL OF 46 PATIENTS RECEIVED LUMBAR DRAINAGE SURGERY. ACCORDING TO THE ARTICLE, SEVEN PATIENTS EXPERIENCED NERVE ROOT IRRITATION. THE ARTICLE STATED THAT THERE WERE TWELVE CASES WHERE THE PATIENTS EXPERIENCED CATHETER OBSTRUCTION. THE ARTICLE ALSO STATED WHEN THE CATHETER WAS INSERTED POINTED DOWNWARDS THERE WERE FEWER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605505 UNKNOWN EDM CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R