MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734048
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
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 the system received an error message, "the system is running in low-graphics mode," along with the ubuntu grub menu appearing.The message appeared three times and had not appeared again since. there was no patient involvement.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736036r, serial/lot #: (b)(6), ubd: , udi#: ; product id: 9735857, serial/lot #: -, ubd: , udi#: ; product id: 9735857, serial/lot #: -, ubd: , udi#: ; product id: 9736408, serial/lot #: -, ubd: , udi#: ; product id: 9736036r, serial/lot #: -, ubd: , udi#: ; product id: 9736032, serial/lot #: -, ubd: , udi#: h3, h6: the system was serviced in the field and the computer, hard drive, and cables were replaced.B01, c13, and d02 are applicable.H6: multiple annex g codes were coded for this event.G02004 was coded for products 9735857.G02007 was coded for products 9736036r, 9736408, and 9736032 multiple annex a codes were coded for this event.A1102 was coded for the error message.A110201 was coded for the ubuntu grub menu.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: a medtronic representative went to the site to test the equipment.Testing revealed that the cables, hard drive and computer were replaced, but there was still no display.It was believed that the computer received for replacement had an out-of-box failure.Pending computer replacement once the new one is received.H6: fdm b01, fdr c13, fdc d02 are applicable to the system checkout.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
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9736036r, lot/serial #: 2119h00069 h3) the computer was returned to the manufacture for analysis.The computer powered on when power was applied.After multiple power cycles no boot up or video issues were observed.The network was set correctly.The video capture card functions correctly.All display ports hdmi and dp all functioned correctly.The sound functions on the hdmi and dp ports.The computer passed all burn-in testing v9.1.The computer was fully functional.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
H2-3) the cable was returned to the manufacturer for evaluation.After functional testing and visual/physical examination, the reported issue was not confirmed.The results of the analysis concluded that no failure was found.Codes: b01, c19, d14 h2) please see section d9 for when the cable was available for 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
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735999, lot number: s5janj0n210093r.H3, h6: the ssd with os (9735999), lot number: s5janj0n210093r, was returned to the manufacturer for analysis.The ssd was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Codes b01, c19, and d14 are applicable to this analysis.The ssd (9736032), lot number: s5janr0na09058j, was returned to the manufacturer for analysis.The ssd logged into an ubuntu screen and then the screen went blank.Further investigation revealed that the ssd hasn't been configured yet.Codes b01, c10, 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
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735762 , version #: 2.1 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) the software team reviewed the case.Logs were not extracting properly and the improper logs which were extracted did not contain the all application logs.Without the proper logs the information provided was insufficient to determine whether a software anomaly contributed to the reported behavior.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.

• Brand Name: STEALTHSTATION® S7¿
• 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: 19668389
• Report Number: 1723170-2024-01637
• Device Sequence Number: 12471394
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050438
• 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,Followup,Followup
• Report Date (Section B): 11/11/2025

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: 9734048
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/07/2024; 05/14/2025; 06/23/2025; 10/13/2025; 11/05/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/17/2024; 08/15/2024; 05/20/2025; 06/25/2025; 10/15/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown