MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Event date is the online publishing date of the literature article.No parts have been received by the manufacturer for evaluation.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.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) #613 stereoelectroencephalography of the insular cortex with intraoperative o-arm.Our experience and results: e-poster viewing.Neuromodulation 2022 25:7 (s236-s237) doi: https://doi.Org/10.1016/j.Neurom.2022.08.269 abstract introduction: refractory epilepsy affects 30% of epileptic patients, with devastating consequences for their personal and professional development.Of those, about 40% could benefit from surgical treatment, provided there is an identifiable accessible epileptic focus.When non-invasive diagnosis is inconclusive, further study is warranted by incursive registration of electrical brain activity with either subdural, epidural or deep electrodes.The latter, known as stereoelectroencephalography (seeg), displays a three dimensional representation of the epileptic zone and permits identification of subcortical aberrancies.Traditional frame-based or the novel robotic-based stereotactic placement of deep electrodes, though very precise, are cumbersome and expensive.Thus, we propose a frameless neuronavigation technique, combined with intraoperative imaging, as a reliable and straightforward alternative.We present our experience and results with an intraoperative 3d fluoroscopic device and an articulated passive arm for seeg electrode placement.Materials /methods: preoperative planning was done with 3d-flair mri to define the target, and contrast-enhanced t1 mri to delineate the trajectory.Surgery was performed under general anesthesia, intraoperative neuronavigation system (stealthstation s8, medtronic, minneapolis, usa) was used to merge preoperative imaging with intraoperative o-arm ® (medtronic, minneapolis, usa) scan acquisition.For electrode insertion, the vertek ® (medtronic, minneapolis, usa) articulated passive arm was employed.We prospectively analyzed patients in which seeg electrodes were implanted with the aforementioned technique (2014-2019).In particular, we were interested in precision, surgical duration, tolerance during seeg monitoring, in-hospital stay, and postoperative complications.Results: a total of 50 patients and 485 electrodes were studied.Mean intraoperative time was 3h.Electrode deviation (a measure of precision) was 1.8 mm (range 0.2 ¿ 5mm).Registration lasted an average of nine days, with excellent tolerance.Mean hospital stay was 12 days.Complication rate was 1%.According to the registration information and eloquence of the areas, 28 of the 50 patients received respective surgery, five received thermocoagulation alone, nine were implanted with vagal nerve stimulator, four were candidates for deep brain stimulation, and nine were not treated.Discussion: co-registration of electric brain activity with deep electrodes and anatomical information obtained with mri, provides a map of epileptic activity and spatiotemporal dissemination.Probabilistic tractography foresees propagation circuits and resting-state functional mri integrates all available information to precisely typify the epileptic network.Conclusions: the presented technique has proven effective, precise and safe, and more convenient than frame-based procedures.Intraoperative o-arm permits meticulous registration, intraoperative redefinition of the target and trajectory and immediate verification of electrode placement.Learning objectives: 1) step-by-step technique: first, the head is fixated with doro ® radiolucent skull-clamp.Next, ct image is obtained with o-arm ®, which allows autoregistration with the neuronavigation system.The entry point is marked in the skin thanks to the passive arm.Skin is cauterized, bone drilled and dura opened.The transcranial screw is fixated manually, the electrode is measured according to the calculated depth, inserted through the screw and secured.After all electrodes have been implanted a final intraoperative ct scan is attained.Verification of target and trajectory of each electrode is done by merging preoperative mri with intraoperative ct.2) when planning the trajectory of deep registration electrodes, we should avoid sulci and ventricles.3) orthogonal trajectories are more efficient and easy to perform intraoperatively.Reported events: the complication rate was 1%.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15963592
• MDR Text Key: 307270392
• Report Number: 3004785967-2022-00824
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1