BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 6031188 · Received October 14, 2016

    Report

    Report Number
    2021898-2016-00374
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    August 30, 2013
    Report Date
    September 16, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. LITERATURE ARTICLE: RISKS FOR HEMORRHAGIC COMPLICATIONS AFTER PLACEMENT OF EXTERNAL VENTRICULAR DRAINS WITH EARLY CHEMICAL PROPHYLAXIS AGAINST VENOUS THROMBOEMBOLISMS AUTHORS: OMAR TANWEER, M.D., AKWASI BOAH, M.D., AND PAUL P. HUANG, M.D. J NEUROSURG 119:1309¿1313, 2013 HTTP://THEJNS.ORG/DOI/ABS/10.3171/2013.7.JNS13313.

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: THE STUDY INCLUDED 99 PATIENTS WITH 111 EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENTS. ACCORDING TO THE REPORT, REASONS FOR EVD PLACEMENT INCLUDED ANEURYSMAL SUBARACHNOID HEMORRHAGE, HYPERTENSIVE THALAMIC AND INTRAVENTRICULAR HEMORRHAGE, TRAUMATIC BRAIN INJURY, AND OTHER (FOR EXAMPLE, STROKE, TUMOR, VASCULAR MALFORMATIONS, INFECTIONS). GROUP ANALYSIS SHOWED A TREND TOWARD DIFFERENCES IN DRAIN-RELATED HEMORRHAGES BASED ON DIAGNOSIS AT TIME OF ADMISSION, BUT STATISTICAL SIGNIFICANCE WAS NOT REACHED. IN THE STUDY, CHEMICAL PROPHYLAXIS WAS STARTED LATER FOR PATIENTS WITH NONLESIONAL INTRACEREBRAL HEMORRHAGES AND EARLIER FOR PATIENTS WITH NONHEMORRHAGIC ETIOLOGIES. REPORTEDLY, DIRECT COMPARISON BETWEEN THE TWO GROUPS FAILED TO SHOW A SIGNIFICANT DIFFERENCE IN THE INCIDENCE OF ANY NEW HEMORRHAGE AFTER PLACEMENT OF A VENTRICULAR DRAIN. THERE WERE ALSO NO SIGNIFICANT DIFFERENCES IN THE RATES OF RADIOGRAPHICALLY SIGNIFICANT HEMORRHAGES. PER THE ARTICLE, IN THE EARLY PROPHYLAXIS GROUP, 3 VENOUS THROMBOEMBOLISMS (VTES) (DEEP VEIN THROMBOSES) WERE DISCOVERED IN 32 PATIENTS SCREENED FOR CLINICALLY SUSPECTED VTES. IN THE DELAYED PROPHYLAXIS GROUP, 5 VTES (3 DEEP VEIN THROMBOSES AND 2 PULMONARY EMBOLISMS) WERE DISCOVERED IN 33 SCREENED FOR CLINICALLY SUSPECTED VTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680704 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization