BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11065266 · Received December 23, 2020

    Report

    Report Number
    1723170-2020-03390
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    January 1, 2013
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INCLUDES THE ARTICLE CITATION. THE LITERATURE ARTICLE IS ATTACHED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EARLY EXPERIENCE WITH MINIMALLY INVASIVE EPILEPSY SURGERY USING LASER ABLATION IN A PEDIATRIC COHORT MILLER I.; RAGHEB J.; BHATIA S.; HYSLOP A. EPILEPSY CURRENTS (2013) 13 SUPPL. 1 (130-131). DATE OF PUBLICATION: MARCH-APRIL 2013 EMBASE LINK HTTPS://WWW.EMBASE.COM/SEARCH/RESULTS?SUBACTION=VIEWRECORD &ID=L71196487 & FROM=EXPORT RATIONALE: THE VISUALASE SYSTEM HAS BEEN FDA-APPROVED FOR THERMAL ABLATION OF SOFT TISSUE IN NEUROSURGERY SINCE 2007. IT HAS MANY TH EORETICAL ADVANTAGES OVER CONVENTIONAL NEUROSURGICAL RESECTION, INCLUDING SMALLER EXPOSURE, SHORTER RECOVERY, AND LESS PAIN. THE SYSTEM ALSO ALLOWS REAL-TIME MR GUIDANCE, WHICH MAY FURTHER IMPROVE SAFETY AND SURGICAL ACCURACY. WHETHER THESE BENEFITS ARE OBSERVED IN CHILDREN UNDERGOING EPILEPSY SURGERY HAS NOT YET BEEN REPORTED. METHODS: MIAMI CHILDREN'S HOSPITAL BEGAN USING THE VISUALASE SYSTEM IN MAY, 2011. WE REPORT ON THE CLINICAL HISTORY, SURGICAL APPROACH, AND OUTCOMES FOR ALL FIVE PATIENTS WITH INTRACTABLE EPILEPSY WHO HAVE BEEN TREATED USING VISUALASE SINCE THAT TIME. INTRAOPERATIVE NEURONAVIGATION INCLUDED BOTH THE LEKSELL STEREOTACTIC SYSTEM, AS WELL AS THE BRAINLAB NAVIGATIONAL SYSTEM. RESULTS: A TOTAL OF FIVE PATIENTS WITH INTRACTABLE EPILEPSY UNDERWENT SURGERY AT MIAMI CHILDREN'S HOSPITAL BETWEEN 5/2011 AND 6/2012. THE MEAN AGE AT SURGERY WAS 14.9 YEARS (RANGE 11.5 TO 18), WITH THE MEAN AGE OF EPILEPSY ONSET OF 7.6 YEARS (RANGE 4-10.7). OF FIVE PATIENTS UNDERGOING VISUALASE SURGERY, THERE WERE SIX TOTAL PROCEDURES. THE ONLY COMPLICATION OBSERVED WAS PLACEMENT-RELATED: ONE PATIENT WAS CONVERTED TO CONVENTIONAL RESECTION, ONE PATIENT REQUIRED A SECOND VISUALASE ABLATION, AND THREE WERE SATISFACTORY. MEAN LENGTH OF STAY WAS 1.6 DAYS (RANGE 1-2). THE WERE NO COMPLICATIONS FROM INFECTION, BLEEDING, OR UNINTENDED NEUROLOGICAL INJURY. TWO PATIENTS WERE ENGEL CLASS I (SEIZURE FREE) AFTER VISUALASE SURGERY, ONE OF WHOM REQUIRED A SECOND VISUALASE ABLATION. IN THE REMAINDER, ONE PATIENT WAS ENGEL CLASS III, ONE PATIENT WAS ENGEL CLASS IV, AND THE FIFTH PATIENT WAS ENGEL CLASS I FOLLOWING CONVERSION TO CONVENTIONAL RESECTION. CONCLUSIONS: MINIMALLY INVASIVE EPILEPSY SURGERY IN CHILDREN IS SAFE AND EFFECTIVE. LENGTH OF STAY IS SHORTER THAN CONVENTIONAL SURGERY, AND WE EXPERIENCED NO UNANTICIPATED COMPLICATIONS. THE BIGGEST FACTOR DETERMINING SUCCESS WAS PRECISE PLACEMENT OF THE LASER FIBER, AND COMPLETE DESTRUCTION OF THE EPILEPTOGENIC ZONE. VISUALASE IS A PROMISING MODE OF TREATMENT FOR INTRACTABLE PEDIATRIC EPILEPSY; SMALL, DEEP LESIONS (SUCH AS THOSE SEEN IN TUBEROUS SCLEROSIS) MAY BE PARTICULARLY AMENABLE TO THIS APPROACH. (FIGURE PRESENTED). REPORTED EVENT(S): 1. ONE PATIENT WAS CONVERTED TO A CONVENTIONAL RESECTION DUE TO A PLACEMENT RELATED ISSUE 2. ONE PATIENT REQUIRED A SECOND ABLATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530921 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention