BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 14271572 · Received May 3, 2022

    Report

    Report Number
    9612501-2022-00709
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    August 30, 2020
    Report Date
    May 2, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED 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

    CHEN, Y.A, HSIEH, C.T., SUN, J.M, EXTRAHEPATIC PSEUDOCYST IN AN ADULT. NEUROSCIENCES. 2021 (26) 97-102. DOI: 10.17712/NSJ.2021.1.20200117 ABSTRACT: VENTRICULOPERITONEAL (VP) SHUNTS ARE COMMONLY USED IN NEUROSURGICAL PROCEDURES TO TREAT HYDROCEPHALUS. ALTHOUGH SHUNT-ASSOCIATED ABDOMINAL COMPLICATIONS ARE WELL DOCUMENTED, EXTRAHEPATIC PSEUDOCYSTS ARE A RARE SHUNT COMPLICATION IN ADULT PATIENTS. THEREFORE, WE HEREIN REPORT THE CASE OF A (B)(6) MALE PATIENT WHO PRESENTED WITH A BULGING MASS AROUND THE PREVIOUS SURGICAL SITE AT THE RIGHT UPPER QUADRANT OF THE ABDOMEN. HE HAD A 4-YEAR HISTORY OF VP SHUNT SURGERY FOR POSTHEMORRHAGIC HYDROCEPHALUS. A COMPUTED TOMOGRAPHIC SCAN REVEALED A LARGE EXTRAHEPATIC PSEUDOCSYT. OUR CASE REPRESENTED A RARE ENTITY OF EXTRAHEPATIC PSEUDOCYST IN ADULT PATIENTS UNDERWENT VP SHUNT SURGERY. THE CLINICAL PRESENTATION, DIAGNOSTIC TOOLS, AND TREATMENT METHODS WERE DISCUSSED. REPORTED EVENTS SMALL CYST-LIKE LESION ON RIGHT ANTERIOR ABDOMEN WALL, A LARGE CYSTIC LESION AT THE RIGHT EXTRAHEPATIC REGION WAS ALSO DISCOVERED. PATIENT UNDERWENT PROCEDURE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762611 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other