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 Cerebrospinal Fluid Leakage (1772)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Certo, f., altieri, r., crimi, s., gurrera, g., cammarata, g., visocchi, m., bianchi, a., barbagallo, g.M.V.Image-guided surgery in complex skull base and facial fractures: initial experience on the role of intra-operative computer tomography.Acta neurochirurgica supplement.135.Https://doi.Org/10.1007/978-3-031-36084-8_11 abstract: cranio-facial fractures (cff) are often a challenge because of the complexity of the anatomy region and the great num-ber of vital s tructures that are located and protected by the cranio-facial bones.Anterior skull base fractures, especially, involves the intracranial compartment with the possibility of a cerebrospinal fluid (csf) leak and the orbit with its contents.Indeed, repair of complex cff involves more than simply ¿putting the pieces together.¿ the goals of surgery include to repair or prevent csf leaks, prevent enophthalmos/hypoglobus, diplopia, reduction of visual acuity, nerves sensory loss, restoration of occlusion, mastication and reconstruction of an esthetic and symmetric facial skeleton [1, 2].The complex anatomy of the region and their pathological modifications makes this surgery a real challenge for surgeons and the reported rate of revision is approximately 15% [3].In recent years, we have tested the efficacy of the intra-operative use of portable ct scans (ict) (portable 8-slices small-bore ct scanner -ceretom®; neurologica, danvers, ma, usa, and a portable full-body 32-slice ct scanner - bodytom® elite, neurologica, danvers, ma, usa) for gliomas surgery [4¿8].The aim of this paper is to retrospectively evaluate our experience of ict in cff surgery to establish if this tool can improve the safety of this complex surgery.Reported events: in one case of i-ct group and in one case of control group further surgery was required because of recurrent csf leakage.

• 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: 18652498
• MDR Text Key: 334725337
• Report Number: 1723170-2024-00458
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 02/02/2024
• 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
• Patient Sex: Male