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

Model Number	9735669
Medical Device Problem Codes	Mechanical Problem (1384); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
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: 9733752, serial/lot #: (b)(6), udi#: (b)(4).H3, h6: a manufacturer representative went to the site to test the equipment.In summary, there was the localizer faulted message during case set up and failure in coils 3,4,5,10.The emitter was replaced.Codes fdm b01, fdr c0201, fdc d02 are applicable to this analysis.D9, h2, h3, h6: the hardware was returned and analysis was performed.The reported complaint ¿system was intermittently displaying a localizer fault¿ was able to be confirmed.The station did fault.The emitter was then tested on the electromagnetic (em) test and it was found to have a tca rom fault.Codes fdm b01, fdr c0201, and fdc d02 are applicable to this analysis.Multiple fdd/annex a codes were reported.A05 was coded for the system intermittently displaying a localizer fault.A1102 was coded for the error message localizer faulted.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.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 prior to a functional endoscopic sinus surgery (fess).It was reported that the system was intermittently displaying a localizer fault.This first occurred on (b)(6) 2026 when a patient was not present.The message resolved itself soon after displaying.This occurred with the site's only flat emitter.Troubleshooting was performed.The medtronic representative (rep) ran printcamera diagnostics-, there was no fault the 1st time, results when the localizer fault message appeared: status: faulted amplifiers enabled: true controller: faulted tca: faulted system faults: transmit coil 3, 4, 5, 10.(same as previous case, controller replaced, no controller faults found in analysis).There was no surgical delay.There was no impact on patient outcome.Additional information was received.It was reported that the intermittent localizer fault messages were appearing when moving the f lat emitter from the bin to the table.The message cleared when the rep put it on the table.Technical services (ts) told rep that the behavior was in line with another case.As issue does not occur while on the table, ts informed rep to complete system checkout.

• 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: 25622481
• Report Number: 1723170-2026-00925
• Device Sequence Number: 9093843
• Product Code: HAW
• UDI-Device Identifier: 00763000360498
• UDI-Public: (01)00763000360498(11)250501(20)01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 06/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 91 KG