MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

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

Patient Problems Micturition Urgency (1871); Intracranial Hemorrhage (1891); Muscle Weakness (1967)

Event Date 07/22/2022

Event Type  Injury  

Event Description

Wang, xin, et al.¿optimized deep brain stimulation surgery to avoid vascular damage: a single-center retrospective analysis of path planning for various deep targets by mri image fusion.¿ brain sciences, vol.12, no.8, 2022, p.967., https://doi.Org/10.3390/brainsci12080967.Abstract: co-registration of stereotactic and preoperative magnetic resonance imaging (mri) images can serve as an alternative for trajectory planning.However, the role of this strategy has not yet been proven by any control studies, and the trajectories of commonly used targets have not been systematically studied.The purpose of this study was to analyze the trajectories for various targets, and to assess the role of trajectories realized on fused images in preventing intracranial hemorrhage (ich).Data from 1019 patients who underwent electrode placement for deep brain stimulation were acquired.Electrode trajectories were not planned for 396 patients, whereas trajectories were planned for 623 patients.Preoperative various mri sequences and frame-placed mri images were fused for trajectory planning.The patients¿ clinical characteristics, the stereotactic systems, intracranial hemorrhage cases, and trajectory angles were recorded and analyzed.No statistically significant differences in the proportions of male patients, patients receiving local anesthesia, and diseases or target distributions (p > 0.05) were found between the trajectory planning group and the non-trajectory planning group, but statistically significant differences were observed in the numbers of both patients and leads associated with symptomatic ich (p <(><<)> 0.05).Regarding the ring and arc angle values, statistically significant differences were found among various target groups (p <(><<)> 0.05).The anatomic structures through which leads passed were found to be diverse.Trajectory planning based on mri fusion is a safe technique for lead placement.The electrode for each given target has its own relatively constant trajectory reported event: 1.One patient with parkinson's disease developed a rare non-hemorrhagic edematous lesion around the trajectory, in the trajectory planned group.An electrode that was placed led to local edema of the posterior limb of the internal capsule (plic) and adjacent white matter.Three days after the patient received bilateral lead placement, he suffered transient urinary incontinence and mild weakness of the right limbs.2.Three patients developed symptomatic intracranial hemorrhage.3.Two patients developed asymptomatic intracranial hemorrhage.See attached literature article.

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent electrode placement for deep brain stimulation as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published date.The article citation is included.The system product number and serial number were not provided in the journal article.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is 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: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15581179
• MDR Text Key: 301571439
• Report Number: 1723170-2022-01633
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• 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: 64 YR
• Patient Sex: Male