BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NON-DELTA VALVE/SHUNT

    MDR report key: 18030202 · Received October 30, 2023

    Report

    Report Number
    2021898-2023-00100
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. A3. 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. A4. PLEASE NOTE THAT THIS WEIGHT IS THE AVERAGE WEIGHT OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL WEIGHT OF PATIENTS INVOLVED WAS NOT PROVIDED. B3. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KUAN HUNG CHEN, PENG WEI HSU, BO CHANG WU, PO HSUN TU, YU CHI WANG, CHENG CHI LEE, YIN CHENG HUANG, CHING CHANG CHEN, CHI CHENG CHUANG, ZHUO HAO LIU. LONG TERM FOLLOW UP AND COMPARISON OF PROGRAMMABLE AND NON PROGRAMMABLE VENTRICULAR CEREBROSPINAL FLUID SHUNTS AMONG ADULT PATIENTS WITH DIFFERENT HYDROCEPHALUS ETIOLOGIES: A RETROSPECTIVE COHORT STUDY. ACTA NEUROCHIRURGICA 165 (2023). DOI: 10.1007/S00701-023-05734-Z ABSTRACT BACKGROUND: PROGRAMMABLE VALVE (PV) HAS BEEN SHOWN AS A SOLUTION TO THE HIGH REVISION RATE IN PEDIATRIC HYDROCEPHALUS PATIENTS, BUT IT REMAINS CONTROVERSIAL AMONG ADULTS. THIS STUDY IS TO COMPARE THE OVERALL REVISION RATE, REVISION CAUSE, AND REVISION-FREE SURVIVAL BETWEEN PV AND NON-PROGRAMMABLE VALVE (NPV) IN ADULT PATIENTS WITH DIFFERENT HYDROCEPHALUS ETIOLOGIES. METHOD: WE REVIEWED THE CHART OF ALL PATIENTS WITH HYDROCEPHALUS RECEIVING INDEX VENTRICULAR CEREBROSPINAL FUID (CSF) SHUNT OPERATIONS CONDUCTED AT A SINGLE INSTITUTION FROM JANUARY 2017 TO DECEMBER 2017. PATIENTS INCLUDED IN THE STUDY WERE FOLLOWED UP FOR AT LEAST 5 YEARS. STATISTICAL TESTS INCLUDING INDEPENDENT T-TEST, CHI-SQUARE TEST, AND FISHER¿S EXACT TEST WERE USED FOR COMPARATIVE ANALYSIS, AND KAPLAN-MEIER CURVE USING LOG-RANK TEST WAS PERFORMED TO COMPARE THE REVISION-FREE SURVIVAL BETWEEN THE PV AND NPV GROUPS. RESULTS: A TOTAL OF 325 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 181 PATIENTS WERE RECEIVING PVS AND 144 PATIENTS RECEIVING NPV. THERE WERE 23 PATIENTS (12.8%) WITH PV AND 22 PATIENTS (15.3%) WITH NPV RECEIVING INITIAL REVISION. NO SIGNIFICANT STATISTICAL DIFFERENCE IN THE INITIAL REVISION RATE WAS OBSERVED BETWEEN THE TWO GROUPS (P=0.52). NO SURVIVAL DEFERENCE WAS FOUND BETWEEN THE PV AND NPV GROUPS. HOWEVER, BETTER REVISION-FREE SURVIVAL WAS NOTED IN THE PV GROUP AMONG IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) (P=0.0274) AND POST-TRAUMATIC HYDROCEPHALUS (P=0.017). CONCLUSIONS: THE COMBINATION OF THE DIFFERENT ETIOLOGIES OF HYDROCEPHALUS AND THE FEATURES OF PV AND NPV RESULTS IN DIFFERENT OUTCOMES¿REVISION RATE AND REVISION-FREE SURVIVAL. PV USE MIGHT BE SUPERIOR TO NPV IN INPH AND POST-TRAUMATIC HYDROCEPHALUS PATIENTS. FURTHER STUDIES ARE NEEDED TO CLARIFY THE INDICATIONS OF PV USE IN ADULT HYDROCEPHALUS PATIENTS. REPORTED EVENTS; (NPV) - THE CAUSES OF THE TOTAL REVISION SURGERIES INCLUDED 16 VALVE-FUNCTION RELATED WHERE 12 WERE OVERSHUNTING WHERE 10 EXPERIENCED SUBDURAL HEMATOMAS AND 4 WAS UNDERSHUNTING; 6 OBSTRUCTIONS WHERE 2 WERE RESERVOIR OBSTRUCTION, 0 WERE PROXIMAL TIP OBSTRUCTION, AND 4 WERE DISTAL TIP OBSTRUCTION; AND 6 WERE INFECTIONS WHERE 5 WERE CNS (CENTRAL NERVOUS SYSTEM) INFECTIONS AND 1 ABDOMINAL INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130629 UNKNOWN NON-DELTA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention