BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 15165154 · Received August 4, 2022

    Report

    Report Number
    2021898-2022-00164
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    April 19, 2022
    Report Date
    August 4, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: NEUROSCIENCES 2022; VOL. 27 (3): 187-190 DOI: 10.17712/NSJ.2022.3.20210140. SUMMARY: LUMBOPERITONEAL (LP) SHUNT IS CONSIDERED AS A UNIQUE PROCEDURE IN NEUROSURGICAL PRACTICE. THE OVER DRAINAGE OF CEREBROSPINAL FLUID (CSF) IS CONSIDERED A USUAL SIDE EFFECT OF THE PROCEDURE THAT USUALLY MANIFESTS IN THE FORM OF SUBDURAL COLLECTION, HEADACHE, OR NAUSEA AND VOMITING. HOWEVER, CRANIAL NERVE PALSY, PARTICULARLY ABDUCENS NERVE PALSY, IS A RARE MANIFESTATION OF CSF OVER DRAINAGE. WE DESCRIBE OUR EXPERIENCE WITH A PATIENT THAT HAS DEVELOPED BILATERAL SIXTH NERVE PALSY FOLLOWED BY LP SHUNT INSERTION, WITH RESOLUTION OF THE SYMPTOMS UPON REMOVAL OF THE SHUNT. THIS SHADES THE LIGHT ON A RARE BUT SIGNIFICANT COMPLICATION RELATED TO LUMBOPERITONEAL (LP) SHUNT INSERTION THAT NECESSITATE THE MODIFICATION IN THE HARDWARE OF VALVE OR INSERTION TECHNIQUE TO DECREASE THE RISK OF CSF OVER THE DRAINAGE. REPORTED EVENT: A 62-YEAR-OLD FEMALE HAD A VALVELESS SHUNT PLACED TO TREAT SURGICAL SITE SUBGALEAL CEREBROSPINAL FLUID (CSF) COLLECTION AFTER A TWO-STAGE LEFT OCCIPITAL MENINGIOMA RESECTION. FIVE DAYS AFTER THE SHUNT WAS PLACED, THE PATIENT BEGAN TO EXPERIENCE A MILD HEADACHE AND DIPLOPIA. THE SYMPTOMS WORSENED AND BECAME CUMBERSOME, AND ON THE SEVENTH DAY POSTOPERATIVELY, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT. SHE WAS DIAGNOSED WITH BILATERAL ABDUCENT CRANIAL NERVE PALSY, WITH THE LEFT SIDE BEING ORE SEVERELY AFFECTED THAN THE RIGHT. THERE WAS INTERVAL IMPROVEMENT IN THE SUBGALEAL COLLECTION. AN MRI SHOWED DIFFUSE PACHYMENINGEAL ENHANCEMENT, WHICH WAS INDICATIVE OF CSF OVERDRAINAGE. THE SHUNT WAS REMOVED. THREE MONTHS LATER, THERE WAS A COMPLETE RESOLUTION OF SIXTH NERVE PALSY WITH NO PROGRESSION IN THE SIZE OF THE SUBGALEAL COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134801 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S -

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R