BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17715134 · Received September 8, 2023

    Report

    Report Number
    1723170-2023-01683
    Event Type
    Death
    Date Received
    September 8, 2023
    Date of Event
    June 10, 2023
    Report Date
    September 14, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE COMPLICATIONS THE PAPER WAS REFERRING TO WERE NOT RELATED TO MEDTRONIC EQUIPMENT.

    Description of Event or Problem · 0

    JOZSA. F., GAIER, C., MA, Y., KITCHEN, N., MCEVOY, A., MISEROCCHI, A., SAMANDOURAS, G., SETHI, H., THOME, L., HILL, C., DARIE, L. SAFETY AND EFFICACY OF BRAIN BIOPSY: RESULTS FROM A SINGLE INSTITUTION RETROSPECTIVE COHORT STUDY. BRAIN AND SPINE. 2023. (101763) HT TPS://DOI.ORG/10.1016/J.BAS.2023.101763 INTRODUCTION: BRAIN BIOPSY PROVIDES IMPORTANT HISTOPATHOLOGICAL DIAGNOSTIC INFORMATION FOR PATIENTS WITH NEW INTRACRANIAL LESIONS. A LTHOUGH A MINIMALLY INVASIVE TECHNIQUE, PREVIOUS STUDIES REPORT AN ASSOCIATED MORBIDITY AND MORTALITY BETWEEN 0.6% AND 6.8%. WE SOUGHT TO CHARACTERISE THE RISK LINKED TO THIS PROCEDURE, AND TO ESTABLISH THE FEASIBILITY OF INSTIGATING A DAY-CASE BRAIN BIOPSY PATHWAY AT OUR INSTITUTION. MATERIALS AND METHODS: THIS SINGLE-CENTRE RETROSPECTIVE CASE SERIES STUDY INCLUDED NEURONAVIGATION GUIDED MINI CRANIOTOMY AND FRAMELESS STEREOTACTIC BRAIN BIOPSIES CARRIED OUT BETWEEN (B)(6) 2019 AND (B)(6) 2021. EXCLUSION CRITERIA WERE INTERVENTIONS PERFORMED FOR NON-NEOPLASTIC LESIONS. DEMOGRAPHIC DATA, CLINICAL AND RADIOLOGICAL PRESENTATION, TYPE OF BIOPSY, HISTOLOGY AND COMPLICATIONS IN THE POST-OPERATIVE PERIOD WERE RECORDED. RESULTS: DATA FROM 196 PATIENTS WITH A MEAN AGE OF 58.7 YEARS (SD+/-14.4 YEARS) WAS ANALYSED. 79% (N=L55) WERE FRAMELESS STEREOTACTIC BIOPSIES AND 21% (N=41) NEURONAVIGATION GUIDED MINI CRANIOTOMY BIOPSIES. COM­PLICATIONS RESULTING IN ACUTE INTRACEREBRAL HAEMORRHAGE AND DEATH, OR NEW PERSISTENT NEUROLOGICAL DEFICITS WERE OBSERVED IN 2% OF PATIENTS (N=4; 2 FRAMELESS STEREOTACTIC; 2 OPEN). LESS SEVERE COMPLICATIONSOR TRANSIENT SYMPTOMS WERE NOTED IN 2.5% OF CASES (N=5). 8 PATIENTS HAD MINOR HAEMORRHAGES IN THE BIOPSY TRACT WITH NO CLINICAL RAMIFICATIONS. BIOPSY WAS NON-DIAGNOSTIC IN 2.5% (N=5) OF CASES. TWO CASES WERE SUBSEQUENTLY IDENTIFIED AS LYMPHOMA. OTHER REASONS INCLUDED INSUFFICIENT SAMPLING, NECROTIC TISSUE, AND TARGET ERROR. DISCUSSION AND CONCLUSION: THIS STUDY DEMONSTRATES THAT BRAIN BIOPSY IS A PROCEDURE WITH AN ACCEPTABLY LOW RATE OF SEVERE COMPLICATIONS AND MORTALITY, IN LINE WITH PREVIOUSLY PUBLISHED LITERATURE. THIS SUPPORTS THE DEVELOPMENT OF DAY-CASE PATHWAY ALLOWING IMPROVED PATIENT FLOW, REDUCING THE RISK OF IATROGENIC COMPLICATIONS ASSOCIATED WITH HOSPITAL STAY, SUCH AS INFECTION AND THROMBOSIS. REPORTABLE EVENTS THREE PATIENTS DIED AS A RESULT OF COMPLICATIONS FOLLOWING BIOPSY (GRADE 4 COMPLICATION, 1.5%), ALL WITH INTRACEREBRAL HAEMORRHAGE PRESENTING AS ACUTE DROP IN GCS WITHIN THE FIRST 2 H FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524732 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death| R