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 Emotional Changes (1831); Pulmonary Emphysema (1832); Unspecified Infection (1930); Seroma (2069); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Hua, w., zhang, x., wang, q., qiu, t., yang, z., wang, x., xu, h., zhang, j., yu, g., fu, m., chen, l., zhu, w., mao, y.Neurosurgical application of pineal region tumor resection with 3d 4k exoscopy via infratentorial approach: a retrospective cohort study.International journal of surgery publish ahead of print.Doi:10.1097/js9.0000000000000707 background: the pineal region tumors are challenging for neurosurgeons and can lead to secondary hydrocephalus.The advent of the exoscope has provided clinical interventions with high image quality and an ergonomic system for pineal region tumor operations.In this study, we describe the exoscopic approach used to facilitate the surgical resection of pineal region tumors and relieve hydrocephalus.Materials and methods: in this retrospective cohort study, we consecutively reviewed clinical and radiological data of 25 patients w ith pineal region lesions who underwent three-dimensional exoscopic tumor resection at a single center.Results: the patient cohort consisted of 16 males and 9 females, with an average age of 34.6 years (range, 6-62 years; 8 cases aged =18).Pathological examination confirmed eight pineal gland tumors, four gliomas, nine germ cell neoplasms, two ependymomas, and two metastatic tumors.Preoperative hydrocephalus was present in 23 patients.Prior to tumor resection, external ventricular drainage (evd) with ommaya reservoir implantation was performed in 17 patients.Two patients received preoperative endoscopic third ventriculostomy (etv), and five patients received a ventriculoperitoneal (vp) shunt, including one who received both procedures.Gross total resection was achieved in 19 patients (76%) in the ¿head-up¿ park bench position using the exoscope.Eight patients (31.6%) with third ventricle invasion received subtotal resection, mainly in glioma cases, which was higher than those without invasion (0%), but not statistically significant (p=0.278, fisher¿s exact test).No new neurological dysfunction was observed after surgery.Two patients (8%) developed intracranial and pulmonary infections, and two patients (8%) suffered from pneumothorax.Hydrocephalus was signific antly relieved in all patients postoperatively, and four patients with relapse hydrocephalus were cured during the long-term follow-up.Postoperative adjuvant management was recommended for indicated patients, and a mean follow-up of 24.8±14.3 months showed a satisfied outcome.Conclusion: the exoscope is a useful tool for pineal region tumor resection and hydrocephalus relief, particularly with posterior third ventricle invasion, as total resection could be achieved without obvious complication.The special superiority of exoscope for indicated pineal region tumors should be highlighted.Reported events two patients (8%) developed intracranial and pulmonary infections two patients (8%) suffered from pneumothorax tentorial subdural hygroma was observed in one case scalp hydrops was seen in one pediatric patient 1 patients had a complication of an unsteady gait 1 patient had a complication of a apathy see literature article.

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) 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: 18211329
• MDR Text Key: 329036086
• Report Number: 1723170-2023-02400
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• 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: 11/02/2023
• 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): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male