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

Model Number	9735669
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The potential cause was suspected to be patient size coupled with swelling from surgical procedures potentially contributing to maximizing the electromagnetic (em) field, such that it could be harder for longer instruments' trackers to optimally be within that em field for tracking.
Additional Manufacturer Narrative
H2: additional information was received and added in section b5.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
Section d references the main component of the system.Other medical products in use during the event include: continuation of d10: product id: 9733752, product id: 9735762, sw version: 2.1.0 h3, h6; a medtronic representative went to the site to test the equipment.The port statuses were all green when connected with tracker and they were unable to replicate complaint.The print camera diagnostics ran with no faults noted.Instruments were tracked and registered as intended.Codes b01, c19, and d14 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 functional endoscopic sinus surgery (fess) procedure.It was reported that the system had trouble verifying and tracking the 90 degree curved suction and straight suction.It was noted that they displayed red with ~3.5 geometry error.There were no issues with verifying the registration probe nor registering the patient.There were no issues with patient tracker.It was noted that the issue was consistent across the whole flat emitter.The manufacturing representative (rep) confirmed that there was no apparent metal interference, the patient's head may have filled the em volume more than typical but no significant distance between head and emitter, all bob ports showed green when connected to instrument tracker, and they had swapped instrument trackers.It was noted that the rep did not have demo head, or nor own instruments to further troubleshoot with.Further troubleshooting was performed.The port statuses were all green when connected with a tracker.They were unable to replicate complaint with original instruments and demo model.Geometry errors: - nipt: 0.38 - straight suction :1.7 - 90-degree suction: 0.3 there was no variation in any when maneuvering them around the surface area of the flat emitter.The printcameradiagnostics showed all ports with no faults and no apparent abnormalities.There was no impact on patient outcome and less than an hour of delay.

• 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: 25161443
• Report Number: 1723170-2026-00737
• Device Sequence Number: 18308229
• Product Code: HAW
• UDI-Device Identifier: 00763000360498
• UDI-Public: (01)00763000360498(11)220113
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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 Age: 34 YR
• Patient Sex: Male
• Patient Weight: 127 KG