BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 14162694 · Received April 20, 2022

    Report

    Report Number
    9612501-2022-00611
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    October 17, 2021
    Report Date
    March 22, 2024
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H6. ANNEX A CODES UPDATED. PREVIOUSLY REPORTED ANNEX A CODES NO LONGER APPLY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    YOKOYA, S., HINO, S., OKA, S. SHEATH FORMATION AROUND PERITONEAL TUBE: POSSIBLE EXPLANATION FOR UNKNOWN CAUSE OF VENTRICULOPERITONEAL SHUNT FAILURE. ACTA NEUROCHIRURGICA. 2021. (163) 3369¿3372. HTTPS://DOI.ORG/10.1007/S00701-021-05023-7. ABSTRACT VENTRICULOPERITONEAL (VP) SHUNT FAILURES ARE COMMON AND ARE FREQUENTLY ASSOCIATED WITH AN OBSTRUCTION OF THE PERITONEAL TUBE. THIS STUDY AIMED TO EXPLORE THE POSSIBLE CAUSES OF PERITONEAL TUBE OBSTRUCTION, WHICH ARE LARGELY UNKNOWN. FROM JANUARY 1981 TO JUNE 2018, WE PERFORMED VP SHUNTING IN 646 PATIENTS WITH HYDROCEPHALUS. AMONG THE PROCEDURES PERFORMED, 148 SHUNT REVISION PROCEDURES WERE PERFORMED IN 98 PATIENTS WITH VP SHUNT FAILURE. OF THE STUDY PARTICIPANTS, 64 (43.2%) PATIENTS WERE DIAGNOSED WITH PERITONEAL TUBE OBSTRUCTION AND FVE PATIENTS DEVELOPED SHEATH FORMATION THAT OBSTRUCTED THE END OF THE PERITONEAL TUBES. SHEATH FORMATION AROUND THE PERITONEAL TUBE IS A POSSIBLE CAUSE OF VP SHUNT DYSFUNCTION. REPORTED EVENTS ONE PATIENT 72 REVISION PROCEDURE, REMOVAL OF THE SHEATH TO MAKE AN ADDITIONAL SLIT. ONE PATIENT 70 REVISION PROCEDURE REMOVAL OF THE SHEATH ONE PATIENT 51 REVISION PROCEDURE, REMOVAL OF THE SHEATH, ADDITIONAL MALFUNCTION 1 MONTH LATER. ONE PATIENT 71 WAS EXPERIENCING ALTERATIONS IN CONSCIOUSNESS. UNDERWENT REVISION PROCEDURE REMOVAL OF THE SHEATH. PATIENT ALSO EXPERIENCED CEREBROSPINAL FLUID (CSF) AT THE TIP OF THE PERITONEAL TUBE ON REMOVAL OF THE FIBROUS CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719676 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other