MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NON-INVASIVE PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734887
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the instrument trackers were not tracking and had a geometry error of >1 mm.After verifying the straight suction, they went to verify the curved suctions and all 3 instrument trackers showed as red in the tracking details and the only thing that was green was the non-invasive patient tracker (nipt), which had a geometry error of 0.8mm.Ports on the break out box (bob) were green except for port 4, which did not have an led when an instrument tracker was plugged into it; they tapped the bob and it turned green after that.They reported there was no metal in field and there was a 3 inch pad between the patient and the bed.It was noted that the "em field seemed smaller than usual" and reported the tracking issues would occur when they were about 12 inches above the flat emitter.They rebooted the system and removed the donut from under the patient and the instruments showed up in the t racking window, the instrument trackers and nipt geometry error dropped to 0.6 mm, but the instrument trackers would flicker red when they reached around 12 inches above the flat emitter.The probable cause was likely metal interference outside of the field.There was a delay of less than one hour.
Additional Manufacturer Narrative
H3/h6: the tracker was returned for analysis.Analysis found that the returned tracker would not track when connected to a known good system, but displayed red status.Codes b01, c02, and d02 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: NON-INVASIVE PATIENT TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21526578
• Report Number: 1723170-2025-01165
• Device Sequence Number: 8335547
• Product Code: HAW
• UDI-Device Identifier: 00763000588373
• UDI-Public: 00763000588373
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: 9734887
• Device Catalogue Number: 9734887
• Device Lot Number: 241002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 63 KG