MAUDE Adverse Event Report: MAZOR ROBOTICS LTD RENAISSANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TPL0038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Dysphasia (2195); Post Operative Wound Infection (2446)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Fenoy a, conner c.Frameless robot-assisted vs frame-based awake deep brain stimulation surgery: an evaluation of technique and new challenges.Oper neurosurg (hagerstown).2022 mar 1;22(3):171-178.Doi: 10.1227/ons.0000000000000059.Abstract: methodological approaches to deep brain stimulation (dbs) continue to evolve from awake frame-based to asleep frameless procedures with robotic assistance, primarily directed to optimize operative efficiency, lead accuracy, and patient comfort.Comparison between the 2 is scarce.To analyze the impacts of methodological differences on operative efficiency and stereotactic accuracy using a frame compared with a frameless robotic platform while maintaining the awake state and use of multiple microelectrode recording (mer) trajectories.Thirty-four consecutive patients who underwent bilateral awake frameless robot-assisted dbs were compared with a previous cohort of 30 patients who underwent frame-based surgery.Patient demographics, operative times, and mer data were collected for both cohorts.Two-dimensional radial errors of lead placements were calculated.Preoperative setup, surgical, and total operating room times were all significantly greater for the robot-assisted cohort (p.001).The need for computed tomography imaging when referencing the robotic fiducials led to increased setup duration because of patient transport, unnecessary for the frame-based cohort.Multiple simultaneous mer trajectories increased surgical time (mean 26 min) for the robot-assisted cohort only.The mean radial errors in the robot-assisted and frame cohorts were 0.98 ± 0.66 and 0.74 ± 0.49 mm (p =.03), respectively.The use of a truly frameless robotic platform such as the mazor renaissance (mazor robotics ltd) presented challenges when implementing techniques used during awake frame-based surgery.Maintaining good accuracy, intraoperative reference imaging, and limited mer trajectories will help integrate frameless robot assistance into the awake dbs surgical workflow.Reported events: twenty-eight patients underwent deep brain stimulation surgery.It was found in one procedure there was a small track of intra-parenchymal hemorrhage that caused transient facial drooping and dysarthria intraoperatively.These issues fully resolved after two weeks.One patient also developed an erosion over their right frontal incision leading to exposure of the electrode after forty days.This led to complete explantation of the system and a course of antibiotics.

Manufacturer Narrative

A.1-a.5) patient information was included in the journal.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.A.4.The patient's weight was no provided.B.3.Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature.B5 included the article citation d.4.The system serial number was not provided in the journal article.H.3.No evaluation was performed as the event was reported as a literature article.H.4.Device manufacturing date was unavailable.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: RENAISSANCE SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18894856
• MDR Text Key: 337556753
• Report Number: 3005075696-2024-00024
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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): Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male