MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC YES; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733533XOM
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the instrument tracker (product: instrument tracker 9733533xom ent 1pk, serial/lot: (b)(6)) was returned to the manufacturer for analysis.Analysis found that there was a tracking/verification issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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 for a functional endoscopic sinus surgery (fess) procedure.It was reported that the patient tracker was tracking initially on its own, but any time the instrument was brought into the field, it would not track, and the instrument tracker would show as red.The manufacturer representative plugged the instrument into a different port with no resolution.They used a new tracker and the issue was resolved.It was noted that this was an out of box failure.There was no delay to the procedure and no impact to patient outcome.

• Brand Name: YES
• 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 ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21407332
• Report Number: 1723170-2025-00807
• Device Sequence Number: 13089202
• Product Code: HAW
• UDI-Device Identifier: 00763000588342
• UDI-Public: 00763000588342
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 241024F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG