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); Mechanical Problem (1384); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
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 system's monitor was cracked.This issue was a continuation of another case, in which the monitor was never replaced.The manufacturer representative (rep) stated that the screen appeared to be zoomed in.Only three of the four rows appeared when the rep brought up a keyboard.Additionally, certain parts of the touch screen were off.When the rep pressed a button, another one nearby activated.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: 9735795, lot number: unknown.H3, h6: no products have been returned to medtronic for analysis.Codes b20, c20, and d15 are applicable.H6: code a0902: display or visual feedback problem is applicable to the screen appeared to be zoomed in and only three of the four rows appeared.Code a1301: failure to read input signal is applicable to certain parts of the touch screen were off and the rep pressed a button and another one nearby activated.Code a05: mechanical problem is applicable to the system's monitor was cracked.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.
Additional Manufacturer Narrative
H3, h6: a manufacturer representative went to the site to test the equipment.In summary, the screen was cracked and unresponsive.The screen was replaced and now working.Codes fdm b01, fdr c13, fdc d02 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.

• 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: 24941586
• Report Number: 1723170-2026-00632
• Device Sequence Number: 8926811
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: (01)00643169838918(11)181020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/02/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2018
• 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
• Patient Sex: Unknown