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 Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Depression (2361)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients 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 is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Ribault, s., simon, e., berthiller, j., polo, g., nunes, a., brinzeu, a., mertens, p., danaila, t., thobois, s., laurencin, c.Comparison of clinical outcomes and accuracy of electrode placement between robot-assisted and conventional deep brain stimulation of the subthalamic nucleus: a single-center study.Acta neurochirurgica 2021 163:1327¿1333https://doi.Org/10.1007/s00701-021-04790-7 background several surgical methods are used for deep brain stimulation (dbs) of the subthalamic nucleus (stn) in parkinson¿s disease (pd).This study aimed to compare clinical outcomes and electrode placement accuracy after robot assisted (ras) versus frame-based stereotactic (fss) stn dbs in parkinson¿s disease.Methods in this single-center open-label study, we prospectively collected data from 48 consecutive pd patients who underwent ras (n euromate®; n = 20) or fss (n = 28) stn dbs with the same mri-based stn targeting between october 2016 and december 2018 in the university neurological hospital of lyon, france.Clinical variables were assessed before and 1 year after surgery.The number of electrode contacts within the stn was determined by merging post-operative ct and pre-operative mri using brainlab® guide¿xt software.Results one year after surgery, the improvement of motor manifestations (p = 0.18), motor complications (p = 0.80), and quality of life (p= 0.30) and the reduction of dopaminergic treatment (p = 0.94) and the rate of complications (p = 0.99) were similar in the two groups.Surgery duration was longer in the ras group (p = 0.0001).There was no difference in the number of electrode contacts within the stn.Conclusion: this study demonstrates that ras and fss stn dbs for pd provide similar clinical outcomes and accuracy of electrode placement.Reported incidents 1 severe psychiatric case where the patient had severe depression 1 subarachnoid hemorrhage accompanied by an intraparenchymal hemorrhage with persistent motor and cognitive disabling 1 subdural hematoma with ad integrum recovery and spontaneous resorption 1 asymptomatic intraparenchymal hemorrhage.1 infection requiring ablation and repositioning of leads and ipg 1 subarachnoid hemorrhage with intraparenchymal hemorrhage without any sequelae 1 junctional cardio-embolic stroke within days after the surgery.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12557230
• MDR Text Key: 274204545
• Report Number: 3004785967-2021-01164
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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: 09/20/2021
• Initial Date FDA Received: 09/30/2021
• 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): Other
• Patient Age: 62 YR