BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 18013288 · Received October 26, 2023

    Report

    Report Number
    2021898-2023-00094
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    August 10, 2023
    Report Date
    October 26, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    B. S. HARHANGI, I. VOIGT, N. DAMEE, P. S. GADJRADJ. SMARTPHONE BASED THERMOGRAPHY TO DETERMINE SHUNT PATENCY IN PATIENTS WITH HYDROCEPHALUS. ACTA NEUROLOGICA BELGICA (2023). DOI: 10.107/S13760-023-02338-3. ABSTRACT BACKGROUND: WHEN SHUNT DYSFUNCTION IS SUSPECTED, RADIATION EXPOSURE DUE TO X-RAYS OR A CT-SCAN IS INEVITABLE. LESS-INVASIVE AND MORE RELIABLE METHODS ARE WARRANTED. IN THIS STUDY, WE AIMED TO ASSESS THE USABILITY OF SMARTPHONE-BASED THERMOGRAPHY TO DETECT SHUNT PATENCY IN PATIENTS WITH HYDROCEPHALUS. METHODS: THIS PROSPECTIVE OBSERVATIONAL PILOT STUDY EVALUATED THE USE OF SMARTPHONE-BASED VIDEO THERMOGRAPHY TO DETECT FLOW OF CEREBROSPINAL FLUID IN THE SHUNT OF 51 PATIENTS FROM THE DEPARTMENT OF NEUROSURGERY AT A TERTIARY REFERRAL INSTITUTE. PATIENTS WITH A SHUNT FOR HYDROCEPHALUS WITHOUT THE SUSPECT OF DYSFUNCTION WERE INCLUDED IN THE STUDY FROM DECEMBER 2021 TO MAY 2022. RESULTS: WE INCLUDED 51 PATIENTS WITH A MEAN AGE OF 53.3 YEARS. OF THESE PATIENTS 14 WERE MALE (27.5%) AND 37 WERE FEMALE (72.5%). THE MOST FREQUENT CAUSE OF THE HYDROCEPHALUS WAS THE NORMAL PRESSURE HYDROCEPHALUS FOLLOWED BY THE CONGENITAL HYDROCEPHALUS. MOST PATIENTS (96%) HAD A VENTRICULOPERITONEAL SHUNT, WHEREAS TWO HAD A VENTRICULO-ATRIAL SHUNT. IN TOTAL, 43 PATIENT (84%) HAD A SHUNT ON THE RIGHT SIDE AND 8 PATIENT (16%) HAD THE SHUNT LOCATED ON THE LEFT SIDE. IN 45 PATIENTS (88.2%), WE OBSERVED A CLEAR FLOW OF CEREBROSPINAL FLUID IN THE COOLED SHUNT TRAJECTORY. CONCLUSIONS: THE FINDINGS OF THIS STUDY INDICATE THAT IN PATIENTS WITH A SHUNT TO TREAT HYDROCEPHALUS, THE SMARTPHONE-BASED VIDEO THERMOGRAPHY MAY BE A SAFE AND SIMPLE ALTERNATIVE TO SHOW SHUNT PATENCY WITHOUT THE EXPOSURE TO RADIATION. REPORTED EVENTS: - IN 5 PATIENTS (9.8%), WE HAD SOME DOUBT ABOUT THE FLOW, AND IN ONE PATIENT (2%), THERE WAS NO FLOW VISIBLE AT ALL BUT WITHOUT SYMPTOMS OF SHUNT DYSFUNCTION. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174968 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female