MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 37612 lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 3389 lot# unknown serial# implanted: explanted: product type lead information references the main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, ubd: , udi#: this value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Luciano furlanetti, jonathan ellenbogen, hortensia gimeno, laura ainaga, vijay narbad, harutomo hasegawa, jean-pierre lin, keyoumars ashkan and richard selway 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.Reported events: it was reported that 2 patient's presented wound site infections and the implants were temporarily removed.It was reported that 3 patients experienced migration with one of their leads, which were revised accordingly.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12036461
• MDR Text Key: 263121616
• Report Number: 2182207-2021-01085
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR