MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735669
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3) no hardware parts have been received by the manufacturer for evaluation.Codes: b17, c20, and d15.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used intra-operatively during a functional endoscopic sinus surgery (fess) procedure.It was reported that there was a navigation system accuracy issue.During sinus surgery, the surgeon penetrated the skull base in the posterior ethmoid on the left side.There was a csf (cerebrospinal fluid) leak, which was detected immediately.Consulted with a neurosurgeon.Closed the csf leak with several layers of tachosil, then mucosa, tissel glue, and mucosa again.There was a mismatch between the navigation system and the actual position in the ethmoid.Further patient impact not provided.Surgical delay not provided.The manufacturer navigation and imaging were aborted.The surgery was aborted.
Event or Problem Description
Additional information was received.The surgery was aborted and the site consulted with another surgeon.The site monitored the patient for a while and saw that the leakage stopped and damage was regressing/healing.It was unknown if a new surgery was planned.No further information available.
Additional Manufacturer Narrative
H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735736, version #: 2.1.0, ubd:- , udi#:- h2) please see section b5 for the additional information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.There was an approximately ten minute long surgical delay.No known impact to patient outcome.The patient was not hospitalized to the icu due to the surgery being aborted and another surgery was not needed to be scheduled.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.The registration accurate was 0.9 mm.The medtronic representatives did not find any issues last time they did troubleshooting.The customer did not do a re-registration.
Event or Problem Description
Additional information was received.The navigation system continued to be fully in use by the clinic.They believed the inaccuracy was related to the scan they imported.It was not related to instruments.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H2-3) the software investigation concluded that there was insufficient information to determine whether a software anomaly contributed to the reported behavior.The provided logs were reviewed and it was observed that one session was on the date of issue reported.In this session, the user transitioned from select procedure to images, registration, registration verify, and navigation.Logs indicated that a single computed tomography (ct) exam was used throughout the workflow.Registration error metrics showed progressive improvement ranging from 2.31 millimeters (mm) to 0.85 mm, calculated using a combination of trace points and touch/image points.The final registration with an error metric of 0.85 mm was used prior to proceeding to navigation, which was consistent with the accuracy (~0.9 mm) reported.The logs also captured "verification succeeded" for the ent instrument tracker on the non-invasive patient tracker.No system errors, registration failures, or tracking faults were observed in the logs that would account for the reported navigation inaccuracy.Although relative movement between the patient anatomy and reference frame post-registration can lead to inaccuracies, there was no evidence in the logs to confirm this.No archives available.Codes: b01, c19, and d15 h2) please see section d9 for when the software was available for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24291287
• Report Number: 1723170-2026-00213
• Device Sequence Number: 10382190
• Product Code: HAW
• UDI-Device Identifier: 00763000360498
• UDI-Public: (01)00763000360498(11)241210
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 02/26/2026; 03/21/2026; 03/27/2026; 05/27/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/25/2026; 03/03/2026; 03/25/2026; 04/01/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown