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 Imprecision (1307)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 04/03/2022

Event Type  malfunction  

Event Description

Giridharan, n., katlowitz, k.A., anand, a., gadot, r., najera, r.A., shofty, b., snyder, r., larrinaga, c., prablek, m., karas, p.J., viswanathan, a., sheth, s.A.Robot-assisted deep brain stimulation: high accuracy and streamlined workflow.Operative neurosurgery 2022.23 (254¿260) doi: 10.1227/ons.0000000000000298 background: a number of stereotactic platforms are available for performing deep brain stimulation (dbs) lead implantation.Robot-assisted stereotaxy has emerged more recently demonstrating comparable accuracy and shorter operating room times compared with conventional frame-based systems.Objective: to compare the accuracy of our streamlined robotic dbs workflow with data in the literature from frame-based and frameless systems.Methods: we retrospectively reviewed 126 consecutive dbs lead placement procedures using a robotic stereotactic platform.Indications included parkinson disease (n = 94), essential tremor (n = 21), obsessive compulsive disorder (n = 7), and dystonia (n = 4).Procedures were performed using a stereotactic frame for fixation and the frame pins as skull fiducials for robot registration.We used intraoperative fluoroscopic computed tomography for registration and postplacement verification.Results: the mean radial error for the target point was 1.06 mm (sd: 0.55 mm, range 0.04- 2.80 mm) on intraoperative fluoroscopic computed tomography.The mean operative time for an asleep, bilateral implant without implantable pulse generator placement was 238 minutes (sd: 52 minutes), and skin-to-skin procedure time was 116 minutes (sd: 42 minutes).Conclusion: we describe a streamlined workflow for dbs lead placement using robot-assisted stereotaxy with a comparable accuracy profile.Obviating the need for checking and switching coordinates, as is standard for frame-based dbs, also reduces the chance for human error and facilitates training.Reported events: two patients had small hemorrhages around one of the leads not requiring intervention.One patient was readmitted for surgical site pain.Across the 253 leads, the mean radial error of the target point on fluoroscopic ct was 1.06 mm.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.) patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.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.If information is provided in the future, a supplemental report will be issued.

• 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: 15538689
• MDR Text Key: 303314945
• Report Number: 3004785967-2022-00649
• 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: 10/04/2022

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: 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: 09/23/2022
• Initial Date FDA Received: 10/04/2022
• 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 Age: 63 YR
• Patient Sex: Male