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

Model Number	9735894
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
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 there were issues at boot up with loading exams or entering procedures.There was no patient involvement.
Additional Manufacturer Narrative
D10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736411, lot number: unknown and product id: 9735823, lot number: unknown g2: foreign country - italy h3/h6: the system was serviced in the field and the issue was confirmed.The planning station didn't boot up properly and the monitor did not retrieve any video signal.Replacing the ssd and the hdmi/dp video cable did not resolve the issue.The old pc was sometimes able to boot up and could be used, but it needed a replacement.The full planning station will be replaced as soon as the new stealthviz license is be released from tech support for the new mac address.Codes b01, c07, and d02 apply.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 medtronic representative went to the site to test the equipment.The pc had been replaced, and the ssd had been reinstalled in the new pc.The system then passed testing.Codes b01, c07 and 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.
Additional Manufacturer Narrative
H2) please see section b5 for additional information that corresponds to annex a code, a0902.H2-3) the manufacturer representative (rep) went to the site to test the navigation system.The high definition multimedia interface (hdmi) display port vide cable was also replaced.Codes: b01, c07, d02 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
Additional information was received.The monitor did not retrieve any video signal.

• Brand Name: STEALTHSTATION¿ S8 PLANNING STATION
• 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: 21417087
• Report Number: 1723170-2025-00823
• Device Sequence Number: 9198696
• Product Code: HAW
• UDI-Device Identifier: 00643169946538
• UDI-Public: 00643169946538
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2025

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: 9735894
• Device Catalogue Number: 9735894
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 02/18/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 02/24/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown