MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER 9734887XOM NON-INVASIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734887XOM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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 during registration, the points were not drawn on the nose.They were "sidle wo where we drawed." after many trials, the accuracy was at 1.7mm overall and about 1mm in the sinus where the healthcare professional wanted to perform surgery.In the surgery, they could prove the inaccuracy with the endoscope and it was about 1cm.The use of the medtronic navigation system was aborted, and a navigation system from another manufacturer was brought in without any accuracy problems.After three times of this problem in the operating room (or), troubleshooting was conducted without any issues found.Another surgery was performed without any registration accuracy problems.However, trackers from a different lot wereutilized.It was suspected that there was an issue with the patient tracker used.There was no reported impact on patient outcome.Clarification was later received in regards to the following statement, "they were 'sidle wo where we drawed.'" points were collected outside on the whole nose.In the 3d model, the points were drawn on the side of the nose and not on top of it.
Additional Manufacturer Narrative
This event was initially reported under regulatory report # 1723170-2024-02709.Additional clarification was received regarding the event date of each occurrence reported, prompting the complaints to be separated.This report is to capture the occurrence on (b)(6) 2024.If any additional information is received it will be submitted under this report number's reference.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.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• 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: 21084315
• Report Number: 1723170-2025-00049
• Device Sequence Number: 8427706
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: 03/06/2026
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 230307B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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 Sex: Unknown