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

Model Number	9735669
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: product id: 9733752.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 instrument tracking became intermittent when navigating in the sinus during an electromagnetic (em) procedure.Technical services (ts) recommended repositioning the flat emitter and ensuring there was no metal in the field.The site did what ts recommended and the issue was no longer present.There was a delay of less than one hout.There was no impact on the patient's outcome.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22131989
• Report Number: 1723170-2025-02169
• Device Sequence Number: 15309683
• Product Code: HAW
• UDI-Device Identifier: 00763000360504
• UDI-Public: 00763000360504
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 70 KG