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

Model Number	9735665
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Application Program Problem (2880); Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the clinical specialist (cs) was receiving a no video detected on main cart.When the cs plugged in the camera cart, it was unable to turn on.The cs attempted to power off the main cart but unable to shut off the blue power button fully off.During troubleshooting, the cs attempted to hard reboot the system with no resolution as the camera cart would not power on and the main cart would not power down fully.The cs disconnected the battery from the system and the main cart finally shut off.Upon rebooting, the cs could hear fans from the main cart.Upon pressing the main cart power button, the main cart would not turn on but the camera cart turned on.After pressing again, both carts were now powered on to the log in screen.The camera cart eventually connected after showing "contacting it" screen for 30 seconds.The cs hard rebooted and powered on the system one more time to ensure issue could not be recreated which was tr ue.The system was now functioning as intended and they could not replicate the no video detected issue after resetting power and communication.There was no patient involvement.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735773, h3, h6: multiple fdd/annex a codes were reported.A0902 was coded for no video detected on main cart.A1102 was coded for no video detected.A070803 was coded for unable to turn on.A0718 was coded for unable to shut off the blue power button fully off, would not power down fully.No products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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: 24911469
• Report Number: 1723170-2026-00616
• Device Sequence Number: 9067513
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: (01)00643169722187(11)180723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/17/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2018
• 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