BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 15421902 · Received September 14, 2022

    Report

    Report Number
    2021898-2022-00187
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 14, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED IN JAPAN, NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. 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

    CITATION: HTTPS://DOI.ORG/10.1038/S41598-022-18209-5 SUMMARY: A NUMBER OF VASCULAR RISK FACTORS (VRFS) HAVE BEEN REPORTED TO BE ASSOCIATED WITH IDIOPATHIC NORMAL-PRESSURE HYDROCEPHALUS (INPH), BUT IT REMAINS UNCLEAR WHETHER THESE VRFS ARE RELATED TO PATIENT OUTCOMES AFTER SHUNT SURGERY. THEREFORE, WE INVESTIGATED THE RISK FACTORS FOR UNFAVOURABLE OUTCOMES AFTER SHUNT SURGERY IN INPH PATIENTS USING TWO SAMPLES FROM TOHOKU UNIVERSITY HOSPITAL AND FROM A MULTICENTRE PROSPECTIVE TRIAL OF LUMBOPERITONEAL (LP) SHUNT SURGERY FOR PATIENTS WITH INPH (SINPHONI-2). WE ENROLLED 158 INPH PATIENTS. WE COMPARED THE PREVALENCE OF VRFS AND CLINICAL MEASURES BETWEEN PATIENTS WITH FAVOURABLE AND UNFAVOURABLE OUTCOMES AND IDENTIFIED PREDICTORS OF UNFAVOURABLE OUTCOMES USING MULTIVARIATE LOGISTIC REGRESSION ANALYSES. THE PRESENCE OF HYPERTENSION, LONGER DISEASE DURATION, MORE SEVERE URINARY DYSFUNCTION, AND A LOWER EVANS¿ INDEX WERE PREDICTORS OF UNFAVOURABLE OUTCOMES AFTER SHUNT SURGERY. IN ADDITION, HYPERTENSION AND LONGER DISEASE DURATION WERE ALSO PREDICTORS IN PATIENTS WITH INDEPENDENT WALKING, AND A LOWER EVANS¿ INDEX WAS THE ONLY PREDICTOR IN PATIENTS WHO NEEDED ASSISTANCE TO WALK OR COULD NOT WALK. OUR FINDINGS INDICATE THAT HYPERTENSION IS THE ONLY VRF RELATED TO UNFAVOURABLE OUTCOMES AFTER SHUNT SURGERY IN INPH PATIENTS. LARGER-SCALE STUDIES ARE NEEDED TO ELUCIDATE THE REASON WHY HYPERTENSION CAN AFFECT THE IRREVERSIBILITY OF SYMPTOMS AFTER SHUNT PLACEMENT. REPORTED EVENT(S): OF 158 PATIENTS, THERE WERE 75 WOMEN AND 83 MEN. THE AVERAGE AGE WAS 76.4 +/- 4.6 YEARS. 71 PATIENTS HAD UNFAVORABLE OUTCOMES. IN THE CURRENT STUDY, A FAVORABLE OUTCOME OF SHUNT IMPLANTATION WAS DEFINED AS AN IMPROVEMENT BY ONE OR MORE POINTS ON THE MRS AT THE 1-YEAR FOLLOW-UP AFTER SHUNT SURGERY. AN UNFAVORABLE OUTCOME WAS ANY THAT DID NOT MEET THIS CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785358 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S -

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male