BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14957323 · Received July 8, 2022

    Report

    Report Number
    1723170-2022-01048
    Event Type
    Death
    Date Received
    July 8, 2022
    Date of Event
    January 9, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT WAS NOT PROVIDED. DATE OF DEATH FOR THE PATIENT WAS NOT PROVIDED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CORRECTING PREVIOUS H10. THE CORRECT PROCEDURE THAT WAS PERFORMED WAS A MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL THERAPY NOT A LATERAL LUMBAR INTERBODY FUSION. 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

    PATEL, P. D., ASHRAF, O., & AMP; DANISH, S. F. (2022). MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL THERAPY FOR BRAINSTEM PATHOLOGIES. WORLD NEUROSURGERY, 161. HTTPS://DOI.ORG/10.1016/J.WNEU.2022.01.040. SUMMARY OBJECTIVE: MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) IS A MINIMALLY INVASIVE AND EFFECTIVE TREATMENT OPTION THAT CAN POTENTIALLY TREAT DEEP SEATED PATHOLOGIES IN CASES WITHOUT SAFE OPEN SURGICAL CORRIDORS. IN THE PRESENT REPORT, WE HAVE DESCRIBED OUR EXPERIENCE USING MRGLITT FOR BRAINSTEM PATHOLOGIES. METHODS: A RETROSPECTIVE MEDICAL RECORD REVIEW AND ANALYSIS WERE CONDUCTED FOR ALL PATIENTS WHO HAD UNDERGONE MRGLITT FOR PATHOLOGIES WITHIN OR CLOSELY SURROUNDING THE BRAINSTEM BETWEEN 2011 AND 2020. THE PATIENTS HAD UNDERGONE STEREOTACTIC LASER PLACEMENT IN THE OPERATING SUITE AND WERE TRANSPORTED TO THE MAGNETIC RESONANCE IMAGING SUITE FOR LASER ABLATION WITH REAL-TIME MONITORING. THE DEMOGRAPHICS, OPERATIVE PARAMETERS, AND COMPLICATIONS WERE RECORDED. RESULTS: A TOTAL OF 12 PATIENTS HAD UNDERGONE MRGLITT FOR BRAINSTEM PATHOLOGIES. THE AVERAGE AGE OF THE PATIENTS WAS 47.6 YEARS (RANGE, 4E75 YEARS). THE PATHOLOGIES INCLUDED BOTH PRIMARY AND METASTATIC INTRACRANIAL TUMORS. THE AVERAGE PREABLATION VOLUME OF THE TARGETS WAS 2.4 +/- 0.50 CM3. THE AVERAGE ABLATION TIME WAS 324.3 +/- 60.7 SECONDS, AND THE AVERAGE POSTABLATION VOLUME WAS 2.92 +/- 0.53 CM3. ONE PERIOPERATIVE MORTALITY WAS DIRECTLY RELATED TO THE PROCEDURE AND 7 PATIENTS DEVELOPED POSTOPERATIVE DEFICITS. TWO PATIENTS HAD EXPERIENCED A RECURRENCE AFTER MRGLITT AND OPTED TO UNDERGO ADDITIONAL ALTERNATIVE TREATMENT. CONCLUSIONS: THE BRAINSTEM REPRESENTS FORMIDABLETERRITORY EVEN FOR MINIMALLY INVASIVE PROCEDURES. THE OVERALL MORBIDITY AND MORTALITY HAS REMAINED HIGH, AND THE PROBABILITY OF ACHIEVING A MEANINGFUL OUTCOME MUST BE CAREFULLY ASSESSED. REPORTED EVENT TWELVE PATIENTS WITH A HISTOLOGY OF DEEP-SEATED INTRACRANIAL TUMORS UNDERWENT MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL THERAPY. ONE PATIENT EXPERIENCED A REFRACTORY EDEMA, WHICH PROGRESSED TO NEUROLOGIC DECLINE AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866196 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other| D