MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number NEU_INS_STIMULATOR

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: product id: 3389, serial/lot#: unknown, implanted, product type lead, product id: 3389, serial/lot#: unknown, product type lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, leads could either be models 3387, 3389, 3391-40.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.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.

Event Description

Xin wang, nan li, jiaming li, huijuan kou, jingwang, jiangpeng jing, mingming su, yang li, liang qu and xuelian wang.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 mdpi journal.Doi: 10.3390/brainsci12080967.Abstract: co-registration of stereotactic and preoperative magnetic resonance imaging (mri) images can serve as an alternative for t rajectory 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 nontrajectory 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 events: 1.It was reported that there were 17 patient's implanted for essential tremor with symptomatic intracranial hemorrhage after the surgery.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15741338
• MDR Text Key: 303148913
• Report Number: 2182207-2022-02061
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male