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

Model Number UNK_OARM_SYS

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Paralysis (1997); Dysphasia (2195)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

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 publishing 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.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.

Event Description

Fenoy, a.J., conner, c.R., frameless robot-assisted vs frame-based awake deep brain stimulation surgery: an evaluation of technique and new challenges.Operative neurosurgery 22:171¿178, 2022.Doi: 10.1227/ons.0000000000000059 background: methodological approaches to deep brain stimulation (dbs) continue to evolve from awake frame-based to asleep frameless procedures with robotic assistance, primarily directed to optimize operative efficiency, lead accuracy, and patient comfort.Comparison between the 2 is scarce.Objective: to analyze the impacts of methodological differences on operative efficiency and stereotactic accuracy using a frame compared with a frameless robotic platform while maintaining the awake state and use of multiple microelectrode recording (mer) trajectories.Methods: thirty-four consecutive patients who underwent bilateral awake frameless robot-assisted dbs were compared with a previous cohort of 30 patients who underwent frame-based surgery.Patient demographics, operative times, and mer data were col-lected for both cohorts.Two-dimensional radial errors of lead placements were calculated.Results: preoperative setup, surgical, and total operating room times were all signif-icantly greater for the robot-assisted cohort.The need for computed to-mography imaging when referencing the robotic fiducials led to increased setup duration because of patient transport, unnecessary for the frame-based cohort.Multiple simul-taneous mer trajectories increased surgical time (mean 26 min) for the robot-assisted cohort only.The mean radial errors in the robot-assisted and frame cohorts were 0.98 ± 0.66 and 0.74 ± 0.49 mm (p =.03), respectively.Conclusion: the use of a truly frameless robotic platform such as the mazor re-naissance (mazor robotics ltd) presented challenges when implementing techniques used during awake frame-based surgery.Maintaining good accuracy, intraoperative reference imaging, and limited mer trajectories will help integrate frameless robot as-sistance into the awake dbs surgical workflow.Reported events: intra-parenchymal hemorrhage that caused transient facial drooping and dysarthria intraoperatively, which was fully resolved by the 2-wk postoperative visit.One patient developed an erosion over his right frontal incision leading to exposure of the electrode at postoperative day 40, which subsequently led to complete explanation of the system and a course of antibiotics see attached literature article.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• 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: 18877180
• MDR Text Key: 337353265
• Report Number: 3004785967-2024-00156
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR