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 Paresis (1998); Meningitis (2389)

Event Date 09/09/2022

Event Type  Injury  

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.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

Devika rajashekar, jose pedro lavrador, prajwal ghimire, hannah keeble, lauren harris, noemia pereira, sabina patel, ahmad beyh, richard gullan, keyoumars ashkan, ranjeev bhangoo and francesco vergani.Simultaneous motor and visual intraoperative neuromonitoring in asleep parietal lobe surgery: dual strip technique.Journal of personalized medicine 12(2022).Doi: 10.3390/jpm12091478 abstract: background: the role played by the non-dominant parietal lobe in motor cognition, attention and spatial awareness networks has potentiated the use of awake surgery.When this is not feasible, asleep monitoring and mapping techniques should be used to achieve an oncofunctional balance.Objective: this study aims to assess the feasibility of a dual-strip method to obtain direct cortical stimulation for continuous real-time cortical monitoring and subcortical mapping of motor and visual pathways simultaneously in parietal lobe tumour surgery.Methods: singlecentre prospective study between 19 may¿20 november of patients with intrinsic non-dominant parietal-lobe tumours.Two subdural strips were used to simultaneously map and monitor motor and visual pathways.Results: fifteen patients were included.With regards to motor function, a large proportion of patients had abnormal interhemispheric resting motor threshold ratio (irmtr) (71.4%), abnormal cortical excitability score (ces) (85.7%), close distance to the corticospinal tract¿ lesion-to-tract distance (ltd)¿4.2 mm, cavity-to-tract distance (ctd)¿7 mm and intraoperative subcortical distance¿6.4 mm.Concerning visual function, the ltd and ctd for optic radiations (or) were 0.5 mm and 3.4 mm, respectively; the mean intensity for positive subcortical stimulation of or was 12 ma ± 2.3 ma and 5/6 patients with deterioration of veps > 50% had persistent hemianopia and transgression of ors.Twelve patients remained stable, one patient had a de-novo transitory hemiparesis, and two showed improvements in motor symptoms.A higher irmtr for lower limbs was related with a worse motor outcome (p = 0.013) and a longer ctd to or was directly related with a better visual outcome (p = 0.041).At 2 weeks after hospital discharge, all patients were ambulatory at home, and all proceeded to have oncological treatment.Conclusion: we propose motor and visual function boundaries for asleep surgery of intrinsic non-dominant parietal tumours.Pre-operative abnormal cortical excitability of the motor cortex, deterioration of the vep recordings and ctd <(><<)> 2 mm from the or were related to poorer outcomes.Reported events: - one had a new contralateral hemiparesis (3/5), which resolved at 3-months.- one patient had meningitis, making a good recovery.See attached literature article.

• 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: 15819511
• MDR Text Key: 303902442
• Report Number: 1723170-2022-01900
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 11/11/2022
• 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: 57 YR
• Patient Sex: Male