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 Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

H3) no parts were returned for analysis.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

Shi j, lu d, pan r, chen h, teng h, xu y, bo f, zhou q and zhang y (2022) applications of diffusion tensor imaging integrated with n euronavigation to prevent visual damage during tumor resection in the optic radiation area.Front.Oncol.12:955418.Doi: 10.3389/fonc.2022.955418 doi: 10.3389/fonc.2022.955418 background: intracranial tumors involving the temporo-occipital lobe often compress or destroy the optic radiation (opr), resulting in decreased visual function.The aim of this study is to explore the value of diffusion tensor imaging (dti) tractography integrated with neuronavigation to prevent visual damage when resecting tumors involving the opr and find potential factors affecting patients¿ visual function and quality of life (qol).Methods: our study is a cross-sectional study that included 28 patients with intracranial tumors in close morphological relationship with the opr recruited between january 2020 and february 2022.The surgical incision and approach were preoperatively designed and adjusted according to the dti tractography results and visual function scores.All patients underwent examinations of visual acuity (va) and visual field index (vfi) and completed visual function and qol scales at admission and 2 months after discharge.Logistic regression and linear regression analysis were conducted to evaluate clinical factors potentially affecting pre/postoperative opr morphology, va, vfi, visual function, and qol.Results: lesion size was the main factor found to affect visual function (b =-0.74, 95%ci: -1.12~-0.36, p = 0.05), va (left: b = -0.11, 95%ci: -0.14~-0.08, p <(><<)> 0.001; right: b = -0.15, 95%ci: -0.17~-0.13, p <(><<)> 0.001), and vfi (left: b =-0.11,95%ci:-0.14~-0.08, p <(><<)> 0.001; right: b = -0.14, 95%ci: -0.16~-0.12, p <(><<)> 0.001).Lesion size, edema, and involvement of the lateral ventricle temporal horn were factors affecting opr morphology and qol.The 28 patients showed significantly improved va, vfi, visual function, and qol results (p <(> <<)> 0.05) 2 months after discharge.Conclusions: combining dti of opr mapping and microscopic-based neuronavigation aided precise mapping and thus preservation of visual function in patients undergoing tumor resection.Potential clinical factors affecting patients¿ visual function and qol scores were identified which are useful for assessing a patient¿s condition and predicting prognosis.Events: 7 patients experienced a transient decrease in visual function after surgery caused by brain tissue edema, no patients had worsening va or vfi two months after discharge.Five patients developed focal impaired awareness autonomic/clonic seizures postoperatively (14).No other discomfort or complications were reported by patients.

• 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: 18340646
• MDR Text Key: 330660583
• Report Number: 1723170-2023-02788
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 11/21/2023
• 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): Life Threatening