MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733881
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a cranial resection procedure.It was reported that during registration and the sterile setup, the active frame was recognized, and the navigation system was in use.However, partway through, tracking the active frame became unreliable.While it was briefly recognized, it failed to be recognized for most of the time.The passive probe tracked without issue.Both the sterile and non-sterile active frames were tested, but no improvement was observed.Restarting the system also did not resolve the issue.Navigation was aborted, and the surgery was completed without navigation. post-surgery, the system was checked but remained unstable.During maintenance, it was determined that the polaris spectra system control unit (scu), breakout box, and active frame × 2 had been discontinued, leading to a transition to the passive frame.The recognition failure and defect occurred during use of the cranial frame.There was no surgical delay and no impact on patient outcome.
Additional Manufacturer Narrative
H2: see h10 - the event was initially reported on time in the other reports: see 1723170-2025-02959;1723170-2025-02960;1723170-2025-02961.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 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.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) additional information added to d4.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,h6: the cranial active frame 9733881, lot number: 170619, was returned to the manufacturer for analysis.The reported problem could not be duplicated.The frame was connected to a test system and all four light emitting diode (led)s were firing without failure.Flexing the cable did not indicate any intermittent opens.The frame was fully functional.No problem was found.Code b01, c19, and d14 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.

• Brand Name: STEALTHSTATION FRAME
• 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; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23157519
• Report Number: 1723170-2025-03330
• Device Sequence Number: 18680515
• Product Code: HAW
• UDI-Device Identifier: 00643169545588
• UDI-Public: (01)00643169545588(11)170619(10)170619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/21/2025

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: 9733881
• Device Catalogue Number: 9733881
• Device Lot Number: 170619
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 10/15/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2017
• 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