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 Cerebrospinal Fluid Leakage (1772); Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The literature article attached to this regulatory report notes the involvement of a stealthstation s7 as well as a stealthstation s8.This report (regulatory report # 802745228) captures the event as reported for the stealthstation s8 system.For the stealthstation s7, refer to regulatory report # 802745227.G2: this event occurred in italy, 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.

Event Description

Citation: https://doi.Org/10.1007/978-3-031-36084-8_11 summary: cranio-facial fractures (cff) are often a challenge because of the complexity of the anatomy region and the great number of vital st ructures 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 intraoperative 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: the study reviewed cases for 12 patients, 10 males and 2 females.In all cases, fractures were caused by high-energy trauma, with a constant involvement of skull-base and facial bones.Indeed, all the cases included in the present study underwent elective surgery, after stabilizing general conditions.The study population was divided into two groups ¿case¿ and ¿control.¿ the case group (total six patients) included all those who underwent intraoperative ct, while the control group (total six patients) included all the patients treated without intraoperative ct.The incidence of re-operation rate was the same in two groups: in one case of i-ct group and in one case of control group further surgery was required because of recurrent cerebrospinal fluid (csf) leakage.

Manufacturer Narrative

H2: it was previously reported that this report, which documents the stealthstation s8, is documented with regulatory report # (b)(4), whereas the report documenting the stealthstation s7 is documented with regulatory report # (b)(4).Both of these regulatory report #s are incorrect.The correct regulatory report # for this report (documenting the s8) is 1723170-2024-00739.The correct regulatory report # to refer to for documentation of the s7 is 1723170-2024-00738.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.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: 18857387
• MDR Text Key: 337123496
• Report Number: 1723170-2024-00739
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 03/04/2024
• 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; Hospitalization
• Patient Sex: Male