BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 15607740 · Received October 14, 2022

    Report

    Report Number
    9612501-2022-01778
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 14, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RETURNED 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

    MATHEUS FERNANDES DE OLIVEIRA. ACTA NEUROLOGICA BELGICA. 121:1799¿1806.PUBLISHED ONLINE: 2 NOVEMBER 2020. DOI: 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 FUID (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 BRAZILIAN TERTIARY HOSPITAL. ALL PATIENTS UNDERWENT CLINICAL EVALUATION, WHICH CONSISTS OF THE MINI-MENTAL STATE EXAMINATION AND TIME UP AND GO TESTS AND THE APPLICATION OF JAPANESE 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 LATEFOLLOW-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. RESULTS EARLY FOLLOW-UP AFTER 1 YEAR OF FOLLOW-UP, THE AVERAGE NUMBER OF ADJUSTMENTS IN VALVE PRESSURE WAS 3.125, VARYING FROM A SINGLE ADJU STMENT IN EIGHT PATIENTS TO SIX ADJUSTMENTS IN OTHER 4 PATIENTS. MEAN MM CHANGED FROM 19 TO 21 (P = 0.03). JSINPH CHANGED FROM 6 TO 4.63 (P=0.016). TUG, WHICH BEFORE SURGERY WAS 41 S, BECAME 35.77 S IN THE FOLLOW-UP (P = 0.01). FORTY-TWO (83%) PATIENTS PRESENTED WITH CLINICAL IMPROVEMENT ACCORDING TO TESTS. DEMENTIA, GAIT AND URINARY INCONTINENCE SYMPTOMS IMPROVED. MID-TERM FOLLOW-UP FORTY-FIVE PATIENTS REACHED MID-TERM FOLLOW-UP. AFTER 4 YEARS OF FOLLOW-UP, THE AVERAGE NUMBER OF ADDITIONAL ADJUSTMENTS IN VALVE PRESSURE DECREASE TO 1.2. MEAN MM CHANGED FROM 21 TO 20 (P>0.05). JSINPH CHANGED FROM 4.63 TO 5.5 (P>0.05). TUG CHANGED FROM 35.77 S TO 38.5 (P>0.05). TWENTY-EIGHT (62%) PATIENTS PRESENTED WITH CLINICAL IMPROVEMENT ACCORDING TO TESTS. DEMENTIA, GAIT AND URINARY INCONTINENCE SYMPTOMS REMAINED IMPROVED, BUT THE IMPROVEMENT WAS LOWER COMPARED TO EARLY FOLLOW-UP. LONG-TERM FOLLOW-UP TWENTY-NINE PATIENTS REACHED LONG-TERM FOLLOW-UP. AT THE FINAL FOLLOW-UP, THE AVERAGE NUMBER OF ADDITIONAL ADJUSTMENTS IN VALVE PRESSURE DECREASED TO 0.4. MEAN MM CHANGED FROM 20 TO 19 (P>0.05), JSINPH CHANGED FROM 5.5 TO 6.5 (P>0.05) AND TUG CHANGED FROM 38.5 S TO 40.5 (P>0.05) (TABLE 2). ELEVEN PATIENTS REMAINED WITH CLINICAL IMPROVEMENT (38%), WHILE 12 (42%) PRESENTED WITH CLINICAL STABILITY AND OTHER SIX (20%) REVEALED CLINICAL DETERIORATION. COMPLICATIONS AT EARLY FOLLOW-UP, THERE WERE 12 COMPLICATIONS IN 9 PATIENTS (18%). 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%). SUBDURAL COLLECTIONS OCCURRED IN SIX PATIENTS (12%). ONE OF THEM DEVELOPED SUBDURAL HYGROMA/HEMATOMA AFTER ONGOING MRI EXAMINATION AND HAVING THE VALVE PRESSURE RESET. FOUR CASES MANAGED CONSERVATIVELY WITH VALVE ADJUSTMENT AND TWO WITH SURGICAL TREATMENT. WE HAD ALSO TWO CASES OF SHUNT INFECTION AND MENINGITIS (4%). ONE PATIENT WITH OVERDRAINAGE, SUBDURAL HEMATOMA AND INFECTION PRESENTED WITH SUBDURAL EMPYEMA AND DIED INSTEAD OF SURGERY AND ANTIBIOTICS TREATMENT. IN MID-TERM FOLLOW-UP WE HAD NO ADDITIONAL INFECTIOUS OR MALFUNCTIONING COMPLICATIONS. HOWEVER, THERE WAS A RETROAURICULAR WOUND DEHISCENCE AND SHUNT EXPOSURE WHICH NEEDED REOPERATION AND VALVE CHANGE. IN CURRENT LONG-TERM FOLLOW-UP WE HAD NO ADDITIONAL MECHANICAL OR INFECTIOUS COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582825 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention