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

Model Number	9735317
Medical Device Problem Codes	Application Program Problem (2880); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a catheter placement procedure.It was reported that the site went to register the patient using the tracer probe and they received a message in the software stating "instrument not verified.Hold instrument tip in verification divot until audible confirmation." the site tried to verify the instrument, even though it isn't required for disposable instruments, and it would not verify.They swapped out the probe with the navigation probe and were able to continue with the case.There was less than an hour delay in surgery.There was no impact on patient outcome.
Additional Manufacturer Narrative
H3/h6: the tracer probe was returned and analyzed.Analysis found that the probe was not recognized when connected to a known good system and would not track.A check of the em interface showed that all three coils were normal.Codes b01, c02, and d02 are applicable.This regulatory report is being submitted due to retrospective review through capa 626390.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: TRACER POINTER
• 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: 21349656
• Report Number: 1723170-2025-00604
• Device Sequence Number: 12726246
• Product Code: HAW
• UDI-Device Identifier: 00763000588441
• UDI-Public: 00763000588441
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 11/21/2024
• Device Model Number: 9735317
• Device Catalogue Number: 9735317
• Device Lot Number: 221122B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 37 KG