BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 20706616 · Received November 18, 2024

    Report

    Report Number
    9612501-2024-02934
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    July 11, 2023
    Report Date
    November 18, 2024
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ZAIYU ZHANG, YUXIN WU, XUELING ZHAO, JIANJUN ZHOU, LUSHENG LI, XUAN ZHAI, PING LIANG. THE INSERTION AND MANAGEMENT OF AN EXTERNAL VENTRICULAR DRAIN IN PEDIATRIC PATIENTS WITH HYDROCEPHALUS ASSOCIATED WITH MEDULLOBLASTOMA. NEUROSURGICAL REVIEW 46 (2023). DOI: 10.1007/S10143-023-02080-7. ABSTRACT AN EXTERNAL VENTRICULAR DRAIN (EVD) IS USED TO FACILITATE CEREBROSPINAL FLUID (CSF) REMOVAL IN MEDULLOBLASTOMA PATIENTS SUFFERING FROM HYDROCEPHALUS. IT IS ESSENTIAL TO RECOGNIZE THAT EVD MANAGEMENT PLAYS A CRUCIAL ROLE IN INFLUENCING THE INCIDENCE OF DRAIN-RELATED COMPLICATIONS. HOWEVER, THE IDEAL METHOD FOR EVD MANAGEMENT REMAINS UNDETERMINED. OUR RESEARCH SOUGHT TO EXAMINE THE SAFETY OF EVD PLACEMENT AND THE IMPACT OF EVD ON THE INCIDENCES OF INTRACRANIAL INFECTIONS, POSTRESECTION HYDROCEPHALUS, AND POSTERIOR FOSSA SYNDROME (PFS). WE CONDUCTED A SINGLE-CENTER OBSERVATIONAL STUDY INVOLVING A COHORT OF 120 PEDIATRIC MEDULLOBLASTOMA PATIENTS WHO WERE TREATED FROM 2017 TO 2020. THE RATES OF INTRACRANIAL INFECTION, POSTRESECTION HYDROCEPHALUS, AND PFS WERE 9.2%, 18.3%, AND 16.7%, RESPECTIVELY. EVD DID NOT INFLUENCE THE OCCURRENCE OF INTRACRANIAL INFECTION (P = 0.466), POSTRESECTION HYDROCEPHALUS (P = 0.298), OR PFS (P = 0.212). A GRADUAL EVD WEANING PROTOCOL CORRELATED WITH AN ELEVATED INCIDENCE OF POSTRESECTION HYDROCEPHALUS (P = 0.033), WHEREAS A RAPID WEANING APPROACH RESULTED IN 4.09 ± 0.44 FEWER DRAINAGE DAYS (P <(><<)> 0.001) THAN THE GRADUAL WEANING STRATEGY. EVD PLACEMENT (P = 0.010) AND INTRACRANIAL INFECTION (P = 0.002) WERE LINKED TO DELAYED SPEECH RETURN, WHEREAS A LONGER DURATION OF DRAINAGE WAS CONDUCIVE TO THE RECOVERY OF LANGUAGE FUNCTION (P = 0.010). EVD INSERTION WAS NOT CORRELATED WITH THE INCIDENCE OF INTRACRANIAL INFECTION, POSTOPERATIVE HYDROCEPHALUS, OR PFS. THE OPTIMAL EVD MANAGEMENT METHOD SHOULD ENCOMPASS A RAPID EVD WEANING STRATEGY, FOLLOWED BY PROMPT DRAIN CLOSURE. WE HAVE PRESENTED ADDITIONAL EVIDENCE TO IMPROVE THE SAFETY OF EVD INSERTION AND MANAGEMENT IN NEUROSURGICAL PATIENTS TO ULTIMATELY FACILITATE THE ESTABLISHMENT OF STANDARDIZED INSTITUTIONAL/NATIONAL IMPLEMENTATION AND MANAGEMENT PROTOCOLS. REPORTED EVENTS - 11 (9.2%) CHILDREN WERE IDENTIFIED WITH INTRACRANIAL INFECTIONS: ECI IN EIGHT (6.7%) AND VENTRICULITIS IN THREE (2.5%). - EVERY PATIENT WITH AN EVD UNDERWENT AN ATTEMPTED EVD WEAN PROTOCOL PRIOR TO CONVERSION TO VPS PLACEMENT OR ETV. TWENTY-TWO PATIENTS REQUIRED PERMANENT CSF DIVERSION, ACCOUNTING FOR 18.3% OF THE STUDY POPULATION¿ONLY 21.3% (16/75) DEVELOPED POSTRESECTION HYDROCEPHALUS. SIX PATIENTS WITHOUT PREOPERATIVE EVD PLACEMENT REQUIRED PERMANENT CSF DIVERSION. IN PATIENTS WITH POSTRESECTION HYDROCEPHALUS, ONLY 3/22 PATIENTS UNDERWENT ETV, AND 19/22 UNDERWENT VPS. - PFS1 (COMPLETE MUTISM) WAS DIAGNOSED IN 14 CHILDREN (11.7%), AND PFS2 (PARTIAL MUTISM) WAS DIAGNOSED IN SIX CHILDREN (5.0%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987090 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other