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

Model Number	9735667
Medical Device Problem Codes	Application Program Problem (2880); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
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: 9735521, serial/lot #: (b)(6), udi#: (b)(4); product id: 9735821r, serial/lot #: (b)(6).H3: a manufacturer representative went to the site to test the equipment.In summary, the side emitter and electromagnetic controller were replaced.Codes fdm b01, fdr c02, fdc d02 are applicable to this analysis.D9, h2, h3: the hardware (9735521) was returned and analysis was performed.The housing was coming apart.Otherwise, the component f unctioned normally.Codes fdm b01, fdr c07, fdc d02 are applicable to this analysis.The hardware (9735821r) was returned and analysis was performed.The returned positioning sensor unit (psu) had scratches on the housing and lenses.A check of the event log showed intermittent firmware incompatibility dating back to oct 2020.There was a battery voltage low message along with bump detected and storage temperature exceeded.The psu failed an accuracy test (aak) at.732mm with a passing threshold of.250mm.Codes fdm b01, fdr c02, fdc 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.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that localizer faulted was intermittently displayed and the side emitter was replaced.Side emitter cable seemed suspect. there was no patient involvement.The cable on the side emitter was kinked.
Additional Manufacturer Narrative
H2) correction: the following concomitant product was excluded from the initial regulatory report (1723170-2025-03861) and should have been included: "continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735824, serial/lot #: unknown,." please see the additional codes section for annex g code associated with product id: 9735824.H2) correction: the following work order statement was submitted on the initial regulatory report, "h3: a manufacturer representative went to the site to test the equipment.In summary, the side emitter and electromagnetic controller were replaced.Codes fdm b01, fdr c02, fdc d02 are applicable to this analysis." this statement should have been as follows: "h3: a manufacturer representative went to the site to test the equipment.In summary, the camera, electromagnetic side mount, and controller were replaced.Codes fdm b01, fdr c02, fdc 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: 9735824r, lot/serial #: (b)(6) h3) the controller was returned for analysis.The reported problem could not be duplicated.The controller was connected to the lat system for over two hours and successfully tracked instruments with the localizer status displaying green status.Controller functioned normally without failure.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.; 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: 23708266
• Report Number: 1723170-2025-03861
• Device Sequence Number: 10649599
• Product Code: HAW
• UDI-Device Identifier: 00643169876972
• UDI-Public: (01)00643169876972(11)190911
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: 9735667
• Device Catalogue Number: 9735667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/15/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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