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

Model Number	9735669
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735795,product id: 9736408 adapter, h3, h6: multiple fdd/annex a codes were reported.A0902 was coded for the monitor displayed 'no video detected'.A1102 was coded for 'no video detected' occurred.Additional troubleshooting was performed.The rep used another monitor.The rep put the new monitor on and used the same cables.The system booted up to no video detected for a couple of seconds and then booted to the password screen.The rep reported the monitor would black out for a second when she would wiggle the hdmi cable.The rep plugged into the other monitor.The monitor remained on 'no video detected screen.' the rep reseated the solid state drive (ssd) - issue unresolved.The rep installed another ssd and booted the system up.The system booted up to 'no video detected' for a couple of seconds and then booted to the password screen.The rep changed the softkeys on the 'old' monitor, system was rebooted and 'no video detected' did not appear on the monitor upon boot up.- issue resolved.No products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Img code g02014 applies to the monitor and g04003 applies to the adapter.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 in an unknown procedure.It was reported that 'no video detected' occurred an hour into a case.The manufacturer representative (rep) moved the monitor and the monitor displayed 'no video detected.' during troubleshooting, the rep rebooted the system 3 times and reseated all of the cables in the back of the monitor.The rep tried 2 other wall outlets and moved to hallway to further troubleshoot.The rep checked the soft keys - issue unresolved.The rep hard rebooted again - issue unresolved.The rep used a known working high-definition multimedia interface(hdmi) cable and plugged in straight from the computer dongle to the monitor.The issue was unresolved.The medtronic navigation system was aborted.Delay information was not provided.It was unknown if there was an impact to the patient.
Additional Manufacturer Narrative
H3: a manufacturer representative went to the site to test the equipment.It was reported that the system still booted up to a ¿no v ideo detected¿ screen, but it only stayed on that screen for about 3-5 seconds before booting to the password screen.It was noted that two surgeries had been performed since with no issue.The adapter would be changed out if the issue persisted.H6: additional review indicated codes d15, b17, c20 are no longer applicable to the event.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 event occurred intra-operatively during a functional endoscopic sinus surgery (fess).There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
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.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21621405
• Report Number: 1723170-2025-01335
• Device Sequence Number: 8535788
• Product Code: HAW
• UDI-Device Identifier: 00763000360504
• UDI-Public: 00763000360504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 04/28/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/18/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Sex: Unknown