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 Problem Paralysis (1997)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Citation: child's nervous system (2023) 39:3595¿3600 https://doi.Org/10.1007/s00381-023-06056-2 summary: introduction: intraparenchymal meningiomas in the basal ganglia are extremely rare, and to the best of our knowledge, only three case reports have been published to date.Owing to concerns regarding major vessels, gross total resection (gtr) is difficult to achieve; therefore, subtotal resection and radiation therapy are often chosen as treatment options.We present a pediatric case with an intraparenchymal meningioma in the left basal ganglia that was successfully treated with gtr.We also reviewed the relevant literature to discuss the pathogenesis, radiological findings, and treatment methods of this rare disease.Case report: a 4-year-old girl presented with progressive right facial paralysis, aphasia, and right incomplete hemiplegia.Imaging revealed a mass lesion in the left basal ganglia and unilateral obstructive hydrocephalus.Neuroendoscopic septostomy, tumor biopsy, and cerebrospinal fluid reservoir placement were performed, and the initial pathological diagnosis was suspected glioma.Thus, craniotomy was performed to remove the tumor, which was white, elastic, and well-defined.Intraoperative rapid pathology revealed a meningioma.Postoperatively, the patient experienced transient worsening of the right incomplete hemiplegia, which subsequently improved.The final pathological diagnosis was a fibrous meningioma.Conclusion: surgery for intraparenchymal meningiomas in the basal ganglia is challenging owing to the proximity of major blood vessels; however, gtr may be preferable to subtotal resection, considering the possibility of recurrence.Even in cases of intraparenchymal reported event: this was a case study of a 4-year-old girl that presented to her physician with progressive right facial paralysis, right incomplete hemiplegia, and aphasia.Neuroendoscopic septostomy, tumor biopsy, and cerebrospinal fluid reservoir placement were performed simultaneously.Postoperatively, the patient experienced transient worsening of the right incomplete hemiplegia, which subsequently improved significantly after the 3-month follow-up.

Manufacturer Narrative

G2: this event occurred in japan, see e1-e3 h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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: 18486370
• MDR Text Key: 332572965
• Report Number: 1723170-2024-00078
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 01/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female