BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

    MDR report key: 7860395 · Received September 10, 2018

    Report

    Report Number
    2021898-2018-00436
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    June 11, 2018
    Report Date
    September 10, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEX. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BO DU, AI-JUN SHAN, YU-PING PENG, JIN WANG, KAI-WEN PENG, XIAN-LIANG ZHONG, AND YUJUAN ZHANG. A NEW MODIFIED NEUROENDOSCOPE TECHNOLOGY TO REMOVE SEVERE INTRAVENTRICULAR HAEMATOMA. BRAIN INJURY 32 (2018). DOI: 10.1080/02699052.2018.1469042 ABSTRACT BACKGROUND: MINIMALLY INVASIVE ENDOSCOPIC HAEMATOMA EVACUATION IS WIDELY USED IN THE TREATMENT OF INTRAVENTRICULAR HAEMORRHAGE. HOWEVER, ITS TECHNIQUE STILL HAS ROOM FOR IMPROVEMENT. A NEW MODIFIED NEUROENDOSCOPE TECHNOLOGY (MNT) WAS USED IN THIS STUDY AND WE EXPLORED ITS SAFETY AND EFFICACY IN THE TREATMENT OF SEVERE ACUTE INTRAVENTRICULAR HAEMORRHAGE BY COMPARING IT WITH EXTRAVENTRICULAR DRAINAGE PLUS UROKINASE THROMBOLYTIC (EVD + UT) THERAPY. METHODS: THE FOLLOWING PARAMETERS WERE COMPARED BETWEEN THE MNT GROUP AND THE CONTROL GROUP: INCISION DESIGN, OPERATION TIME, ICU MONITORING TIME, VENTRICULAR DRAINAGE TUBE (VDT) PLACEMENT TIME, POST-OPERATIVE DRAINAGE TUBE OBSTRUCTION (PDTO) RATE, POST-OPERATIVE COMPLICATIONS RATE, 6-MONTH MORTALITY AND GLASGOW OUTCOME SCALE (GOS). RESULTS: A TOTAL OF 85 PATIENTS WERE ENROLLED. THE ICU MONITORING TIMES, VDT PLACEMENT TIMES, PDTO RATE WERE SHORTER IN THE MNT GROUP. MULTIVARIABLE LOGISTIC REGRESSION IDENTIFIED THAT GOOD MEDIUM-TERM OUTCOME (GOS SCORES 4¿5) WAS SIGNIFICANTLY ASSOCIATED WITH MNT APPLIED (OR 1.017, 95% CI 1.005¿1.029, P = 0.008), AGE UNDER 65 YEARS (OR 4.223, 95% CI, 1.322¿17.109, P = 0.034) AND PRE-OPERATION GCS SCORES MORE THAN 10 (OR 3.427, 95% CI 1.048¿11.205, P = 0.040). CONCLUSION: MNT SURGERY FOR SEVERE INTRAVENTRICULAR HAEMATOMA EVACUATION IS A SAFE AND EFFICIENT NEW SURGICAL OPTION. THIS TECHNIQUE IS MINIMALLY INVASIVE AND MAY BE HELPFUL TO PROVIDE GOOD OUTCOMES FOR SELECTED PATIENTS. REPORTED EVENTS. 1. A TOTAL OF NINE CASES OF DRAINAGE TUBE OBSTRUCTION OCCURRED, ACCOUNTING FOR 22.5% OF THE PATIENTS. 2. A TOTAL OF SIX CASES OF INTRACRANIAL GAS ACCUMULATION OCCURRED. THE INCIDENCE OF INTRACRANIAL GAS ACCUMULATION WAS SIGNIFICANTLY HIGHER IN THE MNT GROUP THAN IN THE CONTROL GROUP. INTRACRANIAL GAS ACCUMULATION OCCURRED MAINLY IN THE BILATERAL FOREHEAD SUBDURAL AND INTRAVENTRICULAR SPACES, AND IT USUALLY DISAPPEARED IN 2¿3 DAYS. POST-OPERATIVE INTRAVENTRICULAR INJECTION OF WATER COULD SIGNIFICANTLY IMPROVE THE INTRAVENTRICULAR GAS ACCUMULATION. BILATERAL FOREHEAD SUBDURAL GAS ACCUMULATION OCCURRED DUE TO THE VOLUME CONTRACTION OF BRAIN TISSUE WHEN USING NEGATIVE PRESSURE TO REMOVE THE HAEMATOMA IN THE VENTRICLE. ONE METHOD USED TO IMPROVE THIS SITUATION CONSISTED OF USING COTTON SHEETS IN THE BRAIN TO PREVENT GAS FROM ENTERING THE DURA FROM THE BONE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700181 UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN-E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1