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

Model Number	9735665
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	04/22/2026
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: 9733752r, serial/lot #: (b)(6) , ubd: , udi#: h3, h6: multiple fdd/annex a codes were reported.A05 was coded for localizer faulted.A1102 was coded for would display "localizer faulted".The system was serviced in the field by a medtronic representative.The flat emitter was replaced to resolve the issue.Codes b01, c07, and d02 are applicable.The 9733752r flat emitter, lot 603003022 was returned for evaluation.Analysis found an electrical failure.The returned flat emitter was tested on a test station and it faulted immediately.It was then tested on a test system and it was found to have a "tcurrtfault" on 4 of 12 coils.Codes b01, c02, and d02 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.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the site was experiencing issues with their flat emitter.The site stated that when the flat emitter was plugged into the system, it would display "localizer faulted." when the medtronic representative (rep) got to the site, he was able to verify this and found that when using the site's side emitter, the message went away.Troubleshooting was performed.Technical services had the rep check the "print camera diagnostics" utility and found that the flat emitter was faulted and the connections on the flat emitter had gone bad.There was no patient involvement.It was reported that technical services (ts) had the clinical specialist (cs) check the "print camera diagnostics" utility and found the flat emitter was reported as faulted.

• 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: 25219453
• Report Number: 1723170-2026-00771
• Device Sequence Number: 18591356
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: (01)00643169722187(11)170925
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 05/19/2026

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: 05/18/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 09/25/2017
• 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