BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CATHETER

    MDR report key: 14596748 · Received June 3, 2022

    Report

    Report Number
    2021898-2022-00128
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    April 15, 2021
    Report Date
    June 13, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AVERAGE AGE OF THE PATIENTS WAS 43 +/- 9.5 YEARS. THE MAJORITY OF THE PATIENTS WERE MALE (13 MALES, 8 FEMALES). PLEASE NOTE THAT THE PRODUCT WAS USED OFF-LABEL. 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.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO THE EVENT DESCRIPTION. 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: EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING (2021) 48:3595¿3605 HTTPS://DOI.ORG/10.1007/S00259-021-05350-Y SUMMARY: OBJECT: GLIOBLASTOMA IS THE MOST COMMON AND MALIGNANT PRIMARY BRAIN TUMOUR, WITH A POOR PROGNOSIS. INTRODUCTION OF NEW TREATMENT OPTIONS IS CRITICALLY IMPORTANT. THE STUDY AIMED TO ASSESS THE APPROPRIATENESS OF ESCALATION DOSES AND TOXICITY OF [225AC]ACDOTA-SP THERAPY. METHODS: A TOTAL OF 21 PATIENTS (AGE OF 43.0 ± 9.5 YEARS), WITH HISTOLOGICALLY CONFIRMED RECURRENT OR CONVERSION GLIOBLASTOMA GRADE 4 FOLLOWING A STANDARD THERAPY, HAVE BEEN INCLUDED IN THE STUDY. ONE TO 2 INTRACAVITARY PORT-A-CATH SYSTEMS WERE STEREOTACTICALLY INSERTED. PATIENTS WERE TREATED WITH ESCALATION DOSE PROTOCOL WITH 10, 20 AND 30 MBQ PER CYCLE TOTALLY 1¿6 DOSES OF [225AC]AC-DOTA-SP IN 2-MONTH INTERVALS. THERAPEUTIC RESPONSE WAS MONITORED BY CLINICAL PERFORMANCE STATUS AND MRI IMAGING. RESULTS: TREATMENT WAS WELL TOLERATED WITH MOSTLY MILD TEMPORARY ADVERSE EFFECTS (OEDEMA, EPILEPTIC SEIZURES, APHASIA, HEMIPARESIS) MAINLY IN THE GROUP OF PATIENTS TREATED WITH 30 MBQ OF [225AC]AC-DOTA-SP. ONLY ONE PATIENT TREATED WITH 30 MBQ REVEALED THROMBOPENIA GRADE 3. THERE WAS NO OTHER GRADE 3 AND 4 TOXICITY RELATED TO [225AC]AC-DOTA-TREATMENT IN ALL GROUPS. THE MEDIAN OVERALL SURVIVAL TIME FROM THE PRIMARY DIAGNOSIS (OS-D) WAS 35.0 MONTHS AND FROM THE DIAGNOSIS OF THE RECURRENCE/CONVERSION (OS-R/C) WAS 13.2 MONTHS. FROM THE START OF TREATMENT WITH [225AC]AC-DOTA-SP, THE MEDIAN PFS WAS 2.4 MONTHS, AND THE OS-T WAS 9.0 MONTHS. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE INVESTIGATED DOSE ESCALATION GROUPS. CONCLUSION: TREATMENT OF RECURRENT GLIOBLASTOMA WITH [225AC]AC-DOTA-SP IS SAFE AND WELL TOLERATED UP TO 30 MBQ PER CYCLE. THE ESCALATION DOSE PROTOCOL SHOWED GOOD TOLERABILITY. ONLY MILD TEMPORARY ADVERSE EFFECTS WERE OBSERVED. NO REMARKABLE HAEMATOLOGICAL, KIDNEY AND LIVER TOXICITY WAS SEEN. REPORTED EVENT: ONE INJECTION WAS INACCURATE DUE TO PARTIAL CONNECTION TO THE VENTRICLES.

    Description of Event or Problem · 0

    THE AUTHOR OF THE LITERATURE ARTICLE RESPONDED AND STATED THAT NONE OF REPORTED SIDE EFFECT IN ARTICLE WERE RELATED TO THE MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031540 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C -

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male