BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA

    MDR report key: 13476392 · Received February 7, 2022

    Report

    Report Number
    2021898-2022-00060
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    November 22, 2021
    Report Date
    February 7, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MIN LI TEY, LEE PING NG, DAVID C. Y. LOW, WAN TEW SEOW AND SHARON Y. Y. LOW. PROGRAMMABLE SHUNT VALVES FOR PEDIATRIC HYDROCEPHALUS: 22-YEAR EXPERIENCE FROM A SINGAPORE CHILDREN¿S HOSPITAL. BRAIN SCIENCES 11 (2021). DOI: 10.3390/BRAINSCI11111548 ABSTRACT: BACKGROUND: PEDIATRIC HYDROCEPHALUS IS A CHALLENGING CONDITION. PROGRAMMABLE SHUNT VALVES (PSV) HAVE BEEN INCREASINGLY USED. THIS STUDY IS UNDERTAKEN TO FIRSTLY, TO OBJECTIVELY EVALUATE THE EFFICACY OF PSV AS A TREATMENT MODALITY FOR PEDIATRIC HYDROCEPHALUS; AND NEXT, REVIEW ITS ASSOCIATED PATIENT OUTCOMES AT OUR INSTITUTION. SECONDARY OBJECTIVES INCLUDE THE ASSESSMENT OF OUR INDICATIONS FOR PSV, AND CORROBORATION OF OUR RESULTS WITH PUBLISHED LITERATURE. METHODS: THIS IS AN ETHICS-APPROVED, RETROSPECTIVE STUDY. VARIABLES OF INTEREST INCLUDE AGE, GENDER, HYDROCEPHALUS ETIOLOGY, SHUNT FAILURE RATES AND INCIDENCE OF ADJUSTMENTS MADE PER PSV. DATA INCLUDING SHUNT FAILURE, IMPLANT SURVIVAL, AND UTILITY COMPARISONS BETWEEN PSV TYPES ARE SUBJECTED TO STATISTICAL ANALYSES. RESULTS: IN THIS CASE, 51 PATIENTS WITH PSV ARE IDENTIFIED FOR THIS STUDY, WITH 32 INDEX AND 19 REVISION SHUNTS. THERE ARE 3 CASES OF SHUNT FAILURE (6%). THE MEAN NUMBER OF ADJUSTMENTS PER PSV IS 1.82 TIMES AND THE MEAN NUMBER OF ADJUSTMENTS MADE PER PSV IS SIGNIFICANTLY LOWER FOR MEDTRONIC¿ STRATA PSVS COMPARED WITH OTHERS (P = 0.031). NEXT, PSV PATIENTS THAT ARE ADJUSTED MORE FREQUENTLY INCLUDE CASES OF SHUNT REVISIONS, PSVS INSERTED DUE TO CSF OVER-DRAINAGE AND TUMOR-RELATED HYDROCEPHALUS. CONCLUSION: WE DESCRIBE OUR INSTITUTIONAL EXPERIENCE OF PSV USE IN PEDIATRIC HYDROCEPHALUS AND ITS ADVANTAGES IN A SUBSET OF PATIENTS WHOSE OPENING PRESSURES ARE UNCERTAIN AND EVOLVING. REPORTED EVENTS: - AMONGST OUR 51 CASES OF PSV PATIENTS, THERE ARE 3 CASES OF SHUNT FAILURE (6%) RELATED EITHER TO SHUNT INFECTION OR MALFUNCTION (FIGURE 5). THESE PATIENTS SUBSEQUENTLY UNDERWENT SHUNT REVISION, EITHER TO A FPV (1 CASE) OR ANOTHER PSV (2 CASES). HERE, 1 PATIENT HAS A HISTORY OF POST-HEMORRHAGIC HYDROCEPHALUS WITH INTERVAL SHUNT INFECTION APPROXIMATELY 2 AND A HALF YEARS LATER; AND DECISION IS MADE TO REVISE THE SHUNT WITH A PSV. ANOTHER PATIENT WITH OBSTRUCTIVE HYDROCEPHALUS SECONDARY TO CRANIOSYNOSTOSIS DEVELOPED PSV SHUNT BLOCKAGE, 8 MONTHS AFTER INSERTION. THIS SHUNT IS SUBSEQUENTLY CHANGED TO ANOTHER PSV WHILE AWAITING DEFINITIVE SURGERY FOR THE CRANIOSYNOSTOSIS. THE LAST PATIENT INITIALLY HAS A PSV SHUNT, BUT THIS IS CHANGED 4 DAYS AFTER INSERTION TO A FPV SHUNT DUE TO SHUNT MALFUNCTION. NOTE: THE MOST COMMON PSV UTILIZED IN OUR UNIT ARE THE CODMAN¿ CERTAS (23 CASES) AND THE MEDTRONIC¿ STRATA (15 CASES), FOLLOWED BY THE MIETHKE¿ PROGAV (9 CASES). THERE ARE 4 PATIENTS (3 CODMAN¿ HAKIM AND 1 SOPHYSA POLARIS®). HOWEVER, THE ARTICLE DID NOT INDICATE IF THE SHUNT FAILURES INVOLVED THE MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904881 STRATA SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R