BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 14188782 · Received April 22, 2022

    Report

    Report Number
    9612501-2022-00631
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    February 1, 2022
    Report Date
    April 22, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE 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

    GORDILLOA, B.F., BENÍTEZ, M.A.P., LEÓNC, M.I.M., IGLESIAS, S. PERITONEAL SHUNTING IN PEDIATRIC PATIENTS AND THE ROLE OF IMAGING IN ITS ASSESSMENT. RADIOLOGY 2022 (64) 136-144. HTTPS://DOI.ORG/10.1016/J.RX.2022.02.001 ABSTRACT LUMBOPERITONEAL SHUNTING MAKES IT POSSIBLE TO REGULATE THE FLOW OF CEREBROSPINAL FLUID BY ESTABLISHING A CONNECTION BETWEEN THE CAL SAC AND THE PERITONEAL CAVITY. THE MAIN INDICATION FOR LUMBOPERITONEAL SHUNTING IN CHILDREN IS IDIOPATHIC INTRACRANIAL HYPERTENSION, BUT THE TECHNIQUE IS ALSO USEFUL IN THE TREATMENT OF POSTINFECTIOUS, POSTHEMORRHAGIC, AND NORMOTENSIVE HYDROCEPHALUS, AS WELL AS IN THE TREATMENT OF POSTSURGICAL PSEUDOMENINGOCELE OR LEAKAGE OF CEREBROSPINAL FLUID. REPORTABLE EVENTS: 1 PATIENT WHERE THE PATIENT HAD HYDROCEPHALUS AFTER THE PROCEDURE, THE DRAIN WAS HYPERDRAINING, THE VALVE WAS NOT WORKING. 1 PATIENT WHERE THE PATIENT CONTRACTED PSEUDOMENINGOCELE POST-SURGICAL PERSISTENT SYMPTOMS WITHOUT VALVE ALTERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199723 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown