MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Dysphasia (2195); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

Stealthstation dbs targeting software and stealth station cranial software were used in the procedures.Specific product information is unavailable.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Citation: doi: 10.1227/ons.0000000000000059 summary: 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 collected for both cohorts.Two-dimensional radial errors of lead placements were calculated.Results: preoperative setup, surgical, and total operating room times were all significantly greater for the robot-assisted cohort (p <.001).The need for computed tomography imaging when referencing the robotic fiducials led to increased setup duration because of patient transport, unnecessary for the frame-based cohort.Multiple simultaneous 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 renaissance (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 assistance into the awake dbs surgical workflow.Reported events: in the robotic-assisted cohort, there were 28 surgeries that were examined retrospectively for this study, 17 male patients and 11 female patients.In the frame cohort, there were 20 patients, 29 male and 9 female.In the robot-assisted cohort, there was a small track intraparenchymal hemorrhage that caused transient facial drooping and dysarthria intraoperatively, which was fully resolved by the 2-week 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 explantation of the system and a course of antibiotics (1/28 hemorrhage, 1/28 erosion/infection).There were no erosions, infections, or hemorrhages during the follow-up period.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18971328
• MDR Text Key: 338554106
• Report Number: 1723170-2024-00891
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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): Hospitalization; Required Intervention