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

Model Number	9735665
Medical Device Problem Codes	Use of Device Problem (1670); Application Program Problem (2880); Device Sensing Problem (2917); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
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: 9 735737, software version: 2.1.0 h3, h6: analysis was performed for this event.In summary, the analysis concluded that 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 the navigation task.Codes b01, c10 and d18 are applicable to this analysis.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 during a cranial resection procedure.It was reported that the system displayed a "low performance" error while attempting to track the microscope dog bone (tracker attached to the microscope).There was less than an hour delay, and no impact on patient outcome.Additional troubleshooting was performed.The system was hooked up to the microscope and tracking dog bone, but the manufacturer representative (rep) was unable to replicate with resin head or with past registration of complaint patient.Imaging slices referenced included 1mm x 1.12mm (axial), 4.4mm x 4.0mm (sagittal), 0.50mm x 1.0mm (sagittal), and 3.0mm x 3.0mm (axial), with some exams noted as not optimal for the navigation system.Additional information was received.It was reported that the system has progressed to prompting 'low performance' error and then becoming unresponsive.Technical services (ts) recommended uninstalling and reinstalling the software.Additional information was received.It was reported that after reinstalling the software, the same 'low performance' error persisted.It was noted that the site deletes patient data every week so there was no concern for storage.

• 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: 24719428
• Report Number: 1723170-2026-00502
• Device Sequence Number: 12265187
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: (01)00763000272739(11)210121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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 Age: 55 YR
• Patient Sex: Male