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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

G2: this event occurred in the united kingdom, see e1-e3.H3, h6: there was no patient present when the issue occurred.Codes b17, c20, and d15 are applicable.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

Citation: https://thejns.Org/doi/abs/10.3171/2023.10.Peds23275 summary: objective: the neurolocate module is a 3d frameless patient registration module that is designed for use with the neuromate stereotactic robot.Long-term electrical stimulation of the globus pallidus internus (gpi) and subthalamic nucleus (stn) via deep brain electrode implantation is particularly successful in a select group of movement disorders in pediatric patients.This study aimed to review the targeting accuracy of deep brain stimulation (dbs) electrode implantation in a single center, comparing standard frame-based techniques to the frameless neurolocate module.Methods: twenty-four pediatric patients underwent implantation of bilateral dbs electrodes under general anesthesia during the period of august 2018¿august 2022.All patients underwent robot-assisted stereotactic implantation of dbs electrodes using an intraoperative o-arm 3d scanner to confirm the final electrode position.These coordinates were compared with the planned entry and target, with attention to depth, radial, directional, and absolute errors, in addition to euclidean distance (ed).The primary outcome evaluated the accuracy and safety of the neurolocate frameless technology compared with standard frame-based techniques.Results: of the 24 bilateral dbs electrode implantations performed, 62.5% used neurolocate technology: 87.5% were delivered to the gpi and the remaining 12.5% to the stn.The mean patient age was 11.0 (range 4¿18) years and 70.8% were male.The median absolute errors in x-, y-, and z-axes were 0.35, 0.75, and 0.9 mm, respectively, using the neurolocate module compared with 0.30, 0.95, and 1.1 mm using the standard frame-based technique.The median ed from the planned target to the actual electrode position with the neurolocate module was 1.28 mm versus 1.69 mm using standard frame-based techniques.No major perioperative complications occurred.Conclusions: stereotactic robot-assisted dbs implantation with the frameless neurolocate module is safe for use in the pediatric population, showing good surgical accuracy and no inferiority to standard frame-based techniques.The neurolocate module for robotic dbs surgery has the potential to improve surgical targeting accuracy, surgical time, patient comfort, and safety.Reported event(s): this was a retrospective, single-center, comparative accuracy and safety study.There were 24 patients, 15 of which were male.The mean age was 11 years.There were two groups observed in this study, those whose procedures were frame-based and those who were frameless.Inaccuracies were reported at both the entry point and the target point with the median radial error (re), and median euclidean distance (ed).For the frame-based group, the overall entry point inaccuracies for the median re and ed were 1.21mm and 2.74mm, respectively.The overall target point inaccuracies for these same values were 1.04mm and 1.69mm, respectively.For the frameless group, the overall entry point inaccuracies for the median re and ed were.88mm and 1.91mm, respectively.The overall target point inaccuracies for these same values were.94mm and 1.28mm, respectively.

• 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: 18619436
• MDR Text Key: 334257619
• Report Number: 3004785967-2024-00072
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

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?: 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: 01/16/2024
• Initial Date FDA Received: 01/31/2024
• 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
• Patient Age: 11 YR
• Patient Sex: Male