MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER 9733533XOM ENT INSTRUMENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733533XOM
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3,h6) no parts have been received by the manufacturer for evaluation.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 during a functional endoscopic sinus surgery (fess) procedure.It was reported that there was an inaccuracy prior to navigation.The navigation instrument did not appear after connection.A new tracker was used to proceed with the case.This resulted in a delay of less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
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
Additional information was received.The system was unable to verify.
Additional Manufacturer Narrative
H3, h6: the tracker was returned to the manufacturer for analysis.The returned tracker had normal recognition and tracking when connected to a known good system.There were no failures found.Codes 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: TRACKER 9733533XOM ENT INSTRUMENT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette CO 80026
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette CO 80026
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22345822
• Report Number: 1723170-2025-02510
• Device Sequence Number: 4888965
• Product Code: HAW
• UDI-Device Identifier: 00613994380012
• UDI-Public: (01)00613994380012(17)260726(10)240726C
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

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 Expiration Date: 07/26/2026
• Device Model Number: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 240726C
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 10/24/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/16/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown