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

Model Number	9735669
Medical Device Problem Codes	Use of Device Problem (1670); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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: 9735736 software, serial/lot #: (b)(6), product id: 9736411 solid state drive, h6: multiple fdd/annex a codes were reported.A23 was coded for low performance error.A1102 were coded for low performance error message and "warning, low system memory".The system was serviced in the field by a medtronic representative.The solid state drive (ssd) was replaced to resolve the issue.Codes b01, c13, and d02 are applicable.A software analysis was initiated.The logs were reviewed.There were 5 sessions on the date of the issue.There was no core file, no database issues, no rabbitmq error, no segfault, and no graphics processing unit (gpu) crash observed on the date of the issue, but the application logs captured multiple instances of ¿cleared user-facing low performance warning" and "posted low performance warning to user" messages in qmlguiservice.The analysis confirmed that low-performance warnings occurred during plan task.The behavior was consistent with a known software issue.Codes b01, c10, and d02 are applicable to the software analysis.Img code g02008 applies to the software and g0200702 applies to the solid-state drive.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 when onsite the manufacturer representative (rep) booted up the system, and a low performance error displayed.To troubleshoot the rep reported deleting 25 patients from system and each patient had a lot of scans that were not relevant to navigation.The rep reported over 800gb available (unknown what it was prior to deleting patients) and log level set to info.The rep rebooted the system and the error no longer appeared when in a procedure.It was agreed to monitor for reoccurrence.No patient was present.It was reported that the system was intermittently displaying the message "warning, low system memory." the site checked the system storage and found that the nurses had deleted all but three patients off the system.It was reported that the "sd" card was replaced, the rep will pull logs to submit at that time.The message was occurring intermittently.The issue was intermittent.Rep saw the message while toggling through menu steps and looking at patient scans.No instruments or hardware parts were in use when rep observed the message.

• 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: 24781843
• Report Number: 1723170-2026-00535
• Device Sequence Number: 18625780
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: (01)00643169838918(11)181121
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 02/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2018
• 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