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 Headache (1880); Paresthesia (4421); Insufficient Information (4580)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

A1-a5) patient information was not included in the journal entry a2) this value reflects the mean age of the patients who underwent deep brain stimulation (dbs) as specific patients could not be identified.A3) this value reflects the majority gender of the patients who dbs as specific patients could not be identified.B3) the article did not provide the date of the procedure.The event date provided is the published date.B5) the article citation is included.D4) the system product number and serial number were not provided in the journal article.Udi not available for this system.G2) no 510k provided as system is unknown.H3) no evaluation was performed as the event was reported as a literature article.H4) device manufacturing date is unavailable.H6) e013403 - tingling e0116 - headache e2401 - jaw clench digital sharing of the article would be in violation of copyright permission.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

Citation: yang, a.I., isbaine, f., alwaki, a., <(>&<)> gross, r.E.(2023).Multitarget deep brain stimulation for epilepsy.Journal of neuro surgery, 1¿8.Https://doi.Org/10.3171/2023.5.Jns23982 summary: objective deep brain stimulation (dbs) is a rapidly growing surgical option for patients with drug-resistant epilepsy who are not candidates for resective/ablative surgery.Recent randomized controlled trials have demonstrated efficacy of dbs of the anterior nucleus of the thalamus (ant), particularly in frontal or temporal epilepsy, whereas dbs of the centromedian (cm) nucleus appears to be most suitable in well-defined generalized epilepsy syndromes.At the authors¿ institution, dbs candidates who did not fit the populations represented in these trials were managed with dbs of multiple distinct targets, which included ant, cm, and less-studied nuclei¿i.E., mediodorsal nucleus, pulvinar, and subthalamic nucleus.The goal of this study was to present the authors¿ experience with these types of cases, and to motivate future investigations that can determine the long-term efficacy of multitarget dbs.Methods this single-center retrospective study of adult patients with drug-resistant epilepsy who underwent multi-target dbs was performed to demonstrate the feasibility and safety of this approach, and to present seizure outcomes.Patients in this cohort had epilepsy with features that were difficult to treat with dbs of the ant or cm nucleus alone, including multifocal/multilobar, diffuse-onset, and/or posterior-onset seizures; or both generalized and focal seizures.Results eight patients underwent dbs of 2¿3 distinct thalamic/subthalamic nuclei.Dbs was performed with 2 electrodes in each hemisphere.All leads in each patient were implanted with either frontal or parietal trajectories.There were no surgical complications.Among those with > 6 months of follow-up (n = 5; range 7¿21 months), all patients were responders in terms of overall seizure frequency and/or convulsive seizure frequency (i.E., = 50% reduction).Two patients had adverse stimulation effects, which resolved with further programming.Conclusions multitarget dbs is a procedurally feasible and safe treatment strategy to maximize outcomes in patients with complex epi lepsy.The authors highlight their approach to inform future studies that are sufficiently powered to assess its efficacy reported events: 1.Eight patient with a history of epilepsy underwent deep brain stimulation (dbs) of 2¿3 distinct thalamic/subthalamic nuclei.Two patients experienced hand tingling during stimulation.2.One patient experienced jaw clenching, which resolved with decreased pulse width.3.One patient experienced transient headaches during stimulation that were ultimately self-resolved.

• 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: 18912850
• MDR Text Key: 337765017
• Report Number: 1723170-2024-00810
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 03/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Male