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 Problem Dyskinesia (2363)

Event Date 05/04/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: un k_visualase_comp, g2: this event occurred in france.H3, h6: no products have been returned to medtronic for analysis.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.

Event Description

Citation: acta neurochirurgica (2023) 165:1453¿1460 https://doi.Org/10.1007/s00701-023-05614-6 summary: background: medically intractable parkinson¿s disease (pd) tremor is a common difficult clinical situation with major impact on patient¿s quality of life(qol).Deep brain stimulation (dbs) is an effective therapy but is not an option for many patients.Less invasive lesional brain surgery procedures, such as thalamotomy, have proven to be effective in these indications.Here, we describe the technical nuances and advantages of stereotactic robot-assisted mri-guided laser interstitial thermal therapy (mrig-litt) thalamotomy for medically intractable pd tremor.Method: we describe 2 patients with medically intractable pd tremor treated with stereotactic robot-assisted mrig-litt thalamotomy performed under general anesthesia with intraoperative electrophysiological testing.Pre and postoperative tremor scores were assessed using the fahn-tolosa-marin tremor rating scale (trs).Results: at 3-month follow-up, both patients demonstrated significant improvement in tremor symptoms subjectively and according to the trs (75% for both).Patients also had substantial improvements in their qol (32.54% and 38%) according to the 39-item pd questionnaire.Both patients underwent uncomplicated mrig-litt thalamotomy.Conclusions: in patients with medically intractable pd tremor who are unsuitable candidates for dbs, thalamotomy utilizing a stereotactic robot, intraoperative electrophysiological testing, and laser ablation with real-time mri guidance may be a viable treatment option.However, further studies with larger sample sizes and longer follow-up periods are necessary to confirm these preliminary results.Reported event(s): there were two patients involved in this study, both female.One patient was 86 years old (patient 1), the other was 65 years old (patient 2).Only patient 1 presented with slight imbalance and slight incoordination of the treated hand, which resolved spontaneously in less than 1 month.

Manufacturer Narrative

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.

• 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 CO 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton,ma CO 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17557123
• MDR Text Key: 321310563
• Report Number: 1723170-2023-01484
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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: 08/08/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 09/28/2023
• 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: 86 YR
• Patient Sex: Female