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

Model Number	9735894
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used intra-operatively in an unknown procedure.It was reported that a magnetic resonance image (mri) series had incorrect orientation, for example the axial views were labeled as coronal, and left/right were flipped.After some unsuccessful troubleshooting, surgeon opted to move forward with the case despite image issues.Patient present, surgical delay pf less than one hour.No known impact to patient outcome.Further troubleshooting was performed, technical services (ts) had the field representative (rep) use the rotate function in the images series.This seemed to fix some of the image issues, but not others.The rep was unable to try the reorient function before the surgeon opted to move forward.The probable cause was noted to be the images may have been labeled incorrectly form the source.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735737, version #: 2.1.0.H3) no hardware parts have been received by the manufacturer for evaluation.Codes: b17, c20, and d15.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.It was reported that the issue occurred during a deep brain stimulation (dbs) procedure.
Additional Manufacturer Narrative
H2: additional information added to b5.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 software analysis concluded that there was insufficient information to determine if a software anomaly caused the reported event.The case was reviewed and from the comments observed that ¿no logs are available as no po was received¿.No logs or exams available.Codes: b01, c19, d15 h2) correction: please see the additional codes section for new annex f code associated with a less than one hour surgical delay.This delay information was submitted in section b5 of the initial rr submitted on 2025-12-01.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 PLANNING STATION
• 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: 23679602
• Report Number: 1723170-2025-03825
• Device Sequence Number: 9661676
• Product Code: HAW
• UDI-Device Identifier: 00763000423179
• UDI-Public: (01)00763000423179(11)210728
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/28/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown