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 Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Nausea (1970); Dysphasia (2195); Cognitive Changes (2551); Convulsion/Seizure (4406)

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Ray, k., krel, m., bernstein, j., kashyap, s., ananda, a.Safety of the transventricular approach to deep brain stimulation: a retrospective review.Surgical neurology international 10 (192-198) doi: 10.25259/sni_244_2019 background: anatomically, deep brain stimulation (dbs) targets such as the ventral intermediate and subthalamic nucleus are positioned such that the long axis of the nucleus is often most accessible through a transventricular trajectory.We hypothesize that using this trajectory does not place patients at increased risk of neurologic complications.Methods: a series of 206 patients at a single institution between 2000 and 2017 were reviewed.All patients had a confirmed transventricular trajectory and their clinical course was reviewed to assess neurologic complication rates in the postoperative period.Results: the average length of hospital stay was 2.4 days.The most common neurologic complication was altered mental status in 1.2% of cases (four patients).This was followed by seizure in 0.6% of cases (two patients).No patients had ischemic stroke or postoperative hemiparesis.There were two mortalities in this series, one with lobar hemorrhage contralateral from the surgical site and one with a thalamic hemorrhage.There was only one confirmed intraventricular hemorrhage postoperatively; however, this was clinically asymptomatic.Conclusion: although the total incidence of intraventricular or intracerebral hemorrhage cannot be reliably assessed from this data set, the low incidence of neurologic complications challenges the notion that dbs electrode trajectories that transgress the ventricle significantly increase the risk of complications.Reportable events: two patients demonstrated suspected seizure activity (0.6%) one patient suffered a postoperative subdural hematoma requiring emergent craniotomy one patient had confirmed intraventricular hemorrhage, but this was clinically asymptomatic.One subdural hematoma and additionally one small sulcal bleed associated with suspected seizure activity, though never confirmed one patient with sdh who was eventually transferred to a rehab facility.Four patients with altered mental status one patient with delirium one patient with lethargy one patient with nausea one patient with aphasia one patient with hyponatremia please see attached literature article.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, 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: 15469710
• MDR Text Key: 303811165
• Report Number: 1723170-2022-01517
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/01/2022
• 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 Age: 64 YR
• Patient Sex: Male