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

Model Number	9734887XOM
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736226, version: 2.1.0 g2: foreign country - germany h2/h6: the software analysis was complete.There was insufficient information to determine whether a software anomaly contributed to the cause of the issue.Codes b01, c19, and d15 apply *this was initially reported on time in the related report as a concomitant product.This report is separating the instrument to be reported with the correct 510(k) number.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 the registration was on the wrong side.The health care professional (hcp) did the registration 3 times.First, the dots of the trace pattern were shown on the left side of the 3-d model.Second, the manufacturer representative (rep) turned on patient reference frame and they had an inaccuracy of 4.4 mm.Third, the registration appeared again on the wrong side of the head on a 3-d model.The hcp traced up and down and left to right and the system showed the dots on the front of the forehead where they were supposed to be.The inaccuracy was still at 1.7 mm.Verifying the registration on specific landmarks of the patient and they were still off by at least 5 mm.The site continued the procedure without navigation.There was no delay to the case.No reported impact to the patient.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• 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: 22490263
• Report Number: 1723170-2025-02687
• Device Sequence Number: 8668752
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: (01)00643169488120(17)261018(10)231019F
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2025

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: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 231019F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: Female