MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT COMPUTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735602R
Medical Device Problem Codes	Mechanical Problem (1384); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3) onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be operational.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: cable 9734250 power 15ft domestic cable 9735546 axiem comm fusion compact system, 9660651, axiem portable.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 the site was having issues where the unit out boot into a "localizer faulted" error, rebooting would resolved the issue each time.The site was getting impatient regarding this issue as it was a daily occurrence.The representative was unable to check for the led number status on the axiem box each time as the site rebooted the unit right away.There was no patient involvement.

• Brand Name: FUSION COMPACT COMPUTER
• 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: 21763528
• Report Number: 1723170-2025-01546
• Device Sequence Number: 8648033
• Product Code: HAW
• UDI-Device Identifier: 00763000099787
• UDI-Public: 00763000099787
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 9735602R
• Device Catalogue Number: 9735602R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Patient Sex: Unknown