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

Model Number	9733858
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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: 9735585, g2: foreign country: india h6: the system was serviced in the field by a medtronic representative (rep).The rep re-integrated the pacs setting in the navigation system.After re-configuration of the picture archiving and communication system (pacs) setting, the patient data was downloading again through the pacs in navigation system.Codes b01, c13, 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.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 there was a facing issue in the navigation system to download patient data through picture archiving and communication system (pacs).The manufacturer representative (rep) re-integrated the pacs setting in the navigation system.After re-configuration of the pacs setting, the patient data was downloading again through the pacs in navigation system.There was no patient involvement.
Additional Manufacturer Narrative
H2 additional information: b5 and section d updated.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
It was reported that the internet protocol (ip) address was reset.They reconfigured as the hospital had changed the ip address series.The picture archiving and communication system (pacs) ip address was changed accordingly.
Additional Manufacturer Narrative
H3/h6: the software analysis was completed.It was found that the issue was a electronic picture archiving and communication systems (pacs) issue and there was no indication of a software anomaly.Codes b01, c19, and d14 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.

• Brand Name: STEALTHSTATION® S7¿
• 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: 22327679
• Report Number: 1723170-2025-02458
• Device Sequence Number: 21191432
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: (01)00643169505742(11)160721(21)N06703451
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 10/23/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/17/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2016
• 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