BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

    MDR report key: 7860448 · Received September 10, 2018

    Report

    Report Number
    2021898-2018-00437
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    June 11, 2018
    Report Date
    September 10, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 EIGHT CASES OF CEREBROSPINAL FLUID LEAKAGE OCCURRED. CEREBROSPINAL FLUID LEAKAGE USUALLY OCCURRED AFTER EXTUBATION, AND IT WAS STOPPED USING A FULL-THICKNESS SCALP SUTURE AND RAISING THE PATIENT¿S HEAD TO 45. 2. A TOTAL OF SEVEN CASES OF INTRACRANIAL INFECTION OCCURRED. INTRACRANIAL INFECTION WAS FOUND BY ROUTINE CEREBROSPINAL FLUID EXAMIN ATION AFTER THE OPERATION AND WAS USUALLY RESOLVED BY INTRATHECAL INJECTION OF VANCOMYCIN (10 MG) EVERY 12 H FOR 3¿5 DAYS. THE INCIDENCE OF INTRACRANIAL INFECTION IN THE CONTROL GROUP WAS HIGHER, WHICH WAS MAINLY DUE TO THE PROLONGED PLACEMENT OF THE VDT, REPEATED INTRAVENTRICULAR INJECTION OF UROKINASE, AND LONGER ICU STAYS AND REHABILITATION TIMES. 3. A TOTAL OF ELEVEN SECONDARY BLEEDS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701768 UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN-E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R