BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 14146913 · Received April 19, 2022

    Report

    Report Number
    9612501-2022-00600
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    November 2, 2020
    Report Date
    April 19, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    OLIVEIRA, M.F., BOA SORTE JR., A.A., EMERENCIANO, D.L., ROTTA, J.M., MENDES, G.A.S., PINTO, F.C.G. LONG TERM FOLLOW-UP OF SHUNTED IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS PATIENTS: A SINGLE CENTER EXPERIENCE. ACTA NEUROLOGICA BELGICA (2021) 121:1799¿1806. HTTPS:// DOI.ORG/10.1007/S13760-020-01538-5. ABSTRACT IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) IS A CONDITION CHARACTERIZED BY GAIT DISTURBANCE, DEMENTIA AND/OR URINARY INCONTINENCE AND ENLARGED VENTRICULAR SYSTEM DUE TO DISTURBANCE OF CEREBROSPINAL FLUID (CSF). THIS STUDY AIMS TO DESCRIBE THE LONG-TERM EXPERIENCE WITH PATIENTS WITH INPH SUBMITTED TO VENTRICULOPERITONEAL SHUNT (VPS) WITH THE PROGRAMMABLE VALVE STRATA® (MEDTRONIC). WE PROSPECTIVELY SELECTED A COHORT OF PATIENTS WITH A DIAGNOSIS OF INPH FROM JANUARY 2010 TO APRIL 2013 IN A (B)(6) HOSPITAL. ALL PATIENTS UNDERWENT CLINICAL EVALUATION, WHICH CONSISTS OF THE MINI-MENTAL STATE EXAMINATION AND TIME UP AND GO TESTS AND THE APPLICATION OF (B)(6) SCALE FOR IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS IN THREE STAGES: PRIOR TO THE TT, 3 H AFTER THE TT AND 72 H AFTER THE TT. FIFTY PATIENTS WERE SUBMITTED TO VPS AND FOLLOWED. THERE WERE 32 MEN AND 18 WOMEN. MEAN AGE WAS 77.1 WITH STANDARD DEVIATION OF 10.9. FOLLOW-UP TIME RANGED FROM 96 TO 120 MONTHS, WITH MEAN OF 106 MONTHS. AFTER 1 YEAR OF FOLLOW-UP, 42 (83%) PATIENTS PRESENTED WITH CLINICAL IMPROVEMENT, DECREASING TO 62% OF PATIENTS AT MID-TERM FOLLOW-UP AND 38% OF PATIENTS AT LATE FOLLOW-UP. COMPLICATIONS OCCURRED IN 18% OF SUBJECTS, NEEDING REOPERATION IN 16%. OUR RESULTS SHOW RELEVANT CLINICAL IMPACT OF SHUNTING IN INPH PATIENTS, DECREASING OVER TIME. COMPLICATIONS SHOULD NOT BE UNDERESTIMATED, REACHING UP TO 18% AND DEMANDING REOPERATION IN 16% OF CASES. THUS, ALTHOUGH MUCH HAS BEEN IMPROVED WITH CURRENT SHUNT TECHNOLOGY, IT IS STILL IMPORTANT TO CONSIDER THE DRAWBACKS OF TREATMENT. REPORTED EVENTS: MALFUNCTIONING OF THE VALVE FORCED THE VALVE REVISION IN TWO PATIENTS (4%) ONE PATIENT PRESENTED WITH WOUND DEHISCENCE AND VALVE EXPOSURE AFTER 6 MONTHS OF THE SURGERY AND IT WAS NECESSARY TO REMOVE THE VALVE (2%) FOUR CASES MANAGED CONSERVATIVELY WITH VALVE ADJUSTMENT AND TWO WITH SURGICAL TREATMENT. TWO CASES OF SHUNT INFECTION AND MENINGITIS (4%). SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409746 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other