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

Model Number	9735669
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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: 9735736, version#: 2.1.0, ubd: , udi#: ; product id: 9735736, version #: 2.1.0, ubd: , udi#:, product id: 9736411r, lot #: unknown.H3) a manufacturer representative (rep) went to the site to test the navigation system.The solid state drive (ssd) was replaced.Codes: b01, c07, and d02 h3) the software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.The logs were reviewed and it was observed there was an issue with connecting to database and due to this issue system could not login.There are no other errors or issues were observed in the logs which have caused this issue.Codes: b01, c1011, d18 h3) the software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.The logs were reviewed which indicated six sessions recorded on the incident date.During the second session, the system graphics process unit (gpu) (nvidia geforce gtx 970, pci:0000:01:00) fell off the pcie bus during login, as evidenced by xid 79 errors.Notably, the syslog contained 7 occurrences of identical xid 79 gpu failures, showed an increasing frequency over time.These failures consistently occurred within minutes after system boot and were not correlated with application workload.No thermal warnings or preceding system errors were observed prior to these events.The observed behavior was consistent with a hardware-level pcie communication failure affecting gpu stability.These symptoms align with a known issue.Codes: b01, c10, d18 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 outside of a procedure.It was reported that whenever the manufacturer representative (rep) attempted to log in to the clinical application, the system would pause for a few moments before kicking they back to the login screen.While the rep was using the clinical application, the screen went unresponsive.The rep performed a hard reboot of the system and the issue was resolved upon boot.It was noted that the probable cause of the issue was the solid state drive (ssd).There was no patient involvement.

• 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: 25281042
• Report Number: 1723170-2026-00796
• Device Sequence Number: 18561240
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: (01)00643169838918(11)181022
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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