BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATA®

    MDR report key: 15374264 · Received September 7, 2022

    Report

    Report Number
    9612501-2022-01540
    Event Type
    Death
    Date Received
    September 7, 2022
    Date of Event
    July 12, 2022
    Report Date
    September 7, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. 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

    GOH, E.T., LOCK, C., TAN, A.J.L., TAN, B.L., LIANG, S., PILLAY, R., KUMAR, S., AHMAD-ANNUAR, A., NARAYANAN, V., KWOK, J., TAN, Y.J., NG, A.S., TAN, E.K., CZOSNYKA, Z., CZOSNYKA, M., PICKARD, J.D., KEONG, N.C. CLINICAL OUTCOMES AFTER VENTRICULO-PERITONEAL SHUNTING IN PATIENTS WITH CLASSIC VS. COMPLEX NPH. JOURNAL FRONTIERS IN NEUROLOGY. 2022 (13:868000) DOI: 10.3389/FNEUR.2022.868000 OBJECTIVE: NORMAL PRESSURE HYDROCEPHALUS (NPH) IS A NEUROLOGICAL CONDITION CHARACTERIZED BY A CLINICAL TRIAD OF GAIT DISTURBANCE, COGNITIVE IMPAIRMENT, AND URINARY INCONTINENCE IN CONJUNCTION WITH VENTRICULOMEGALY. OTHER NEURODEGENERATIVE DISEASES, SUCH AS ALZHEIMER¿S DISEASE, PARKINSON¿S DISEASE, AND VASCULAR DEMENTIA SHARE SOME OVERLAPPING CLINICAL FEATURES. HOWEVER, THERE IS EVIDENCE THAT PATIENTS WITH COMORBID NPH AND ALZHEIMER¿S OR PARKINSON¿S DISEASE MAY STILL EXHIBIT GOOD CLINICAL RESPONSE AFTER CSF DIVERSION. THIS STUDY AIMS TO EVALUATE CLINICAL RESPONSES AFTER VENTRICULO-PERITONEAL SHUNT (VPS) IN A COHORT OF PATIENTS WITH COEXISTING NPH AND NEURODEGENERATIVE DISEASE. METHODS: THE STUDY HAS TWO COMPONENTS; (I) A PILOT STUDY WAS PERFORMED THAT SPECIFICALLY FOCUSED UPON PATIENTS WITH COMPLEX NPH AND FOLLOWING THE INCLUSION OF THE COMPLEX NPH SUBTYPE INTO CONSIDERATION FOR THE CLINICAL NPH PROGRAMME, (II) A RETROSPECTIVE SNAPSHOT STUDY WAS PERFORMED TO CONFIRM AND CHARACTERIZE DIFFERENCES BETWEEN CLASSIC AND COMPLEX NPH PATIENTS BEING SEEN CONSECUTIVELY OVER THE COURSE OF 1 YEAR WITHIN A WORKING SUBSPECIALIST NPH CLINIC. WE STUDIED THE CHARACTERISTICS OF PATIENTS WITH COMPLEX NPH, UTILIZING CLINICAL RISK STRATIFICATION AND MULTIMODAL BIOMARKERS. RESULTS: THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN RESPONDERS AND NON-RESPONDERS TO CSF DIVERSION ON COMORBIDITY SCALES. AFTER VPS INSERTION, SIGNIFICANTLY MORE CLASSIC NPH PATIENTS HAD IMPROVED COGNITION COMPARED TO COMPLEX NPH PATIENTS (P = 0.005). IMPROVEMENT IN GAIT AND URINARY SYMPTOMS DID NOT DIFFER BETWEEN THE GROUPS. 26% OF THE CLASSIC NPH GROUP SHOWED GLOBAL IMPROVEMENT OF THE TRIAD, AND 42% IMPROVED IN TWO DOMAINS. ALTHOUGH ONLY 8% SHOWED GLOBAL IMPROVEMENT OF THE TRIAD, ALL COMPLEX NPH PATIENTS IMPROVED IN GAIT. GOH ET AL. CLASSIC VS. COMPLEX NPH VPS OUTCOMES CONCLUSIONS: OUR STUDY HAS DEMONSTRATED THAT THE PRESENCE OF NEURODEGENERATIVE DISORDERS CO-EXISTING WITH NPH SHOULD NOT BE THE SOLE BARRIER TO THE CONSIDERATION OF HIGH-VOLUME TAP TEST OR LUMBAR DRAINAGE VIA A SPECIALIST NPH PROGRAMME. FURTHER CHARACTERIZATION OF DISTINCT COHORTS OF NPH WITH DIFFERING DEGREES OF CSF RESPONSIVENESS DUE TO OVERLAY FROM NEURODEGENERATIVE OR COMORBIDITY RISK BURDEN MAY AID TOWARD MORE PRECISE PROGNOSTICATION AND TREATMENT STRATEGIES. WE PROPOSE A SIMPLISTIC CONCEPTUAL FRAMEWORK TO DESCRIBE NPH BY ITS CLASSIC VS. COMPLEX SUBTYPES TO PROMOTE THE CLINICAL PARADIGM SHIFT TOWARD SUBSPECIALIST GERIATRIC NEUROSURGERY BY ADDRESSING NEEDS FOR RAPID SCREENING TOOLS AT THE CLINICAL-RESEARCH INTERFACE. REPORTABLE EVENTS: PILOT STUDY: OF THE NON-RESPONDERS, ONE PATIENT DIED FROM A CEREBROVASCULAR ACCIDENT AND ANOTHER IMPROVED POST DISCHARGE BUT DECLINE D INTERVENTION RETRO STUDY: TWO PATIENTS PASSED AWAY WITHIN 3 YEARS OF SHUNT INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236752 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death