BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 13803930 · Received March 18, 2022

    Report

    Report Number
    9612501-2022-00428
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    November 18, 2020
    Report Date
    March 17, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ASENSIO-SÁNCHEZ, V.M., PACHECO-CALLIRGOS, G.E., VALENTÍN-BRAVO, J., GARCÍA-ONRUBIA, L. VISUAL ACUITY LOSS AND SIXTH NERVE PALSY AS THE ONLY MANIFESTATIONS OF SLIT VENTRICLE SYNDROME. ARCH SOC ESP OFTALMOL. 2022 97(1):40¿43 ABSTRACT THE CASE IS PRESENTED OF A GIRL DIAGNOSED WITH OBSTRUCTIVE HYDROCEPHALUS DUE TO PILOMYXOID ASTROCYTOMA, WHICH REQUIRED A VENTRICULOPERITONEAL SHUNT (VPS) AT THE AGE OF (B)(6) YEARS AND (B)(6) MONTHS. TWO MONTHS LATER, MAGNETIC RESONANCE IMAGING OF THE BRAIN DID NOT SHOW VENTRICULOMEGALY OR OTHER SIGNS OF INCREASED INTRACRANIAL PRESSURE. AT THE AGE OF (B)(6) YEARS AND (B)(6) MONTHS, A RAPID ONSET OF BILATERAL VISUAL ACUITY LOSS DEVELOPED AND SHE WAS DIAGNOSED WITH SLIT VENTRICLE SYNDROME. DESPITE VALVE REVISIONS OF THE VPS, SHE DEVELOPED AN ABRUPT DECLINE OF VISUAL ACUITY TO HAND MOTION AT 10 CM. (B)(6) EXAMINATION REVEALED BILATERAL OPTIC ATROPHY. SHE DID NOT REPORT ANY OTHER SYSTEMIC SYMPTOMS SUGGESTING INCREASED INTRACRANIAL PRESSURE, SUCH AS HEADACHE, NAUSEA, VOMITING, LETHARGY, IRRITABILITY, OR ALTERED LEVELS OF CONSCIOUSNESS. REPORTABLE EVENTS TWO MONTHS AFTER SURGERY, MRI SHOWED COLLAPSE OF THE LATERAL VENTRICLES AND BILATERAL FRONTAL DRAINAGE VALVE WITH NO OTHER SIGNS OF INCREASED INTRACRANIAL PRESSURE. THE PATIENT HAD DIFFICULTY SEE FAR AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697112 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Other