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 Problem Post Operative Wound Infection (2446)

Event Date 04/16/2021

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

Furlanetti, l., ellenbogen, j., gimeno, h., ainaga, l., narbad, v., hasegawa, h., lin, j.P., ashkan, k., selway, r.Targeting accuracy of robot-assisted deep brain stimulation surgery in childhood-onset dystonia: a single-center prospective cohort analysis of 45 consecutive cases.J neurosurg pediatr 2021 (27) 677¿687 doi: 10.3171/2020.10.Peds20633.Objective deep brain stimulation (dbs) is an established treatment for pediatric dystonia.The accuracy of electrode implantation is multifactorial and remains a challenge in this age group, mainly due to smaller anatomical targets in very young patients compared to adults, and also due to anatomical abnormalities frequently associated with some etiologies of dystonia.Data on the accuracy of robot-assisted dbs surgery in children are limited.The aim of the current paper was to assess the accuracy of robot-assisted implantation of dbs leads in a series of patients with childhood-onset dystonia.Methods forty-five children with dystonia undergoing implantation of dbs leads under general anesthesia between 2017 and 2019 were included.Robot-assisted stereotactic implantation of the dbs leads was performed.The final position of the electrodes was verified with an intraoperative 3d scanner (o-arm).Coordinates of the planned electrode target and actual electrode position were obtained and compared, looking at the radial error, depth error, absolute error, and directional error, as well as the euclidean distance.Functional assessment data prospectively collected by a multidisciplinary pediatric complex motor disorders team were analyzed with regard to motor skills, individualized goal achievement, and patients¿ and caregivers¿ expectations.Results a total of 90 dbs electrodes were implanted and 48.5% of the patients were female.The mean age was 11.0 ± 0.6 years (range 3¿18 years).All patients received bilateral dbs electrodes into the globus pallidus internus.The median absolute errors in x-, y-, and z-axes were 0.85 mm (range 0.00¿3.25 mm), 0.75 mm (range 0.05¿2.45 mm), and 0.75 mm (range 0.00¿3.50 mm), respectively.The median euclidean distance from the target to the actual electrode position was 1.69 ± 0.92 mm, and the median radial error was 1.21 ± 0.79.The robot-assisted technique was easily integrated into the authors¿ surgical practice, improving accuracy and efficiency, and reducing surgical time significantly along the learning curve.No major perioperative complications occurred.Conclusions robot-assisted stereotactic implantation of dbs electrodes in the pediatric age group is a safe and accurate surgical method.Greater accuracy was present in this cohort in comparison to previous studies in which conventional stereotactic frame-based techniques were used.Robotic dbs surgery and neuroradiological advances may result in further improvement in surgical targeting and, consequently, in better clinical outcome in the pediatric population.Patient events 2 patients presented with wound site infection for which the implants were temporarily removed.3 patients experienced migration of one of the dbs leads, which were revised accordingly.

• 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: 13359031
• MDR Text Key: 288650288
• Report Number: 3004785967-2022-00056
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2022

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: 01/04/2022
• Initial Date FDA Received: 01/26/2022
• 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 Outcome(s): Other
• Patient Age: 11 YR
• Patient Sex: Female