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

Model Number	9735669
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
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:sw app 9735762, software version: 2.1.0 h3 and h6: no products have been returned to medtronic for analysis.Codes b17, c20, d15 are applicable.  a23 applies to difficulty with registering the patient.A0908 applies to trace would jump over to the patient's right.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 in an unknown procedure.It was reported that there was difficulty with registering the patient.The site noted that after completing a trace registration, the trace would jump over to the patient's right. troubleshooting was performed. technical support (ts) had the site reposition the reference frame closer to the patient.The site was able to successfully register after moving the frame.The issue was resolved on the call. the length of the surgical delay is pending.The patient outcome is pending.
Additional Manufacturer Narrative
H2-3) the software analysis concluded that the software appeared to be operating as intended.The logs were reviewed.They captured 2 sessions on the date of the issue; however, there were no indications of abnormalities related to the shift in the registration.According to the provided screenshot, the patient's head was not included in the scans, which resulted in a smaller area for collecting the trace points.As per the stealth imaging protocol, it was recommended to include the patient's tip of the nose and the head in the scans to obtain a larger area for tracing and to enhance accuracy.Based on the troubleshooting information, the issue was addressed after repositioning the reference frame closer to the patient.There was no evidence to suggest that a software anomaly contributed to the reported behavior.Codes: b01, c19, d14 h2) please see section d9 for when the software was available for evaluation.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¿ 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: 20500075
• Report Number: 1723170-2024-03245
• Device Sequence Number: 17955598
• Product Code: HAW
• UDI-Device Identifier: 00763000360450
• UDI-Public: 00763000360450
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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