MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. AXIEM¿; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735016
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Malleable suction wouldn't register with medtronic stealth machine.

• Brand Name: AXIEM¿
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 20673920
• Report Number: 20673920
• Device Sequence Number: 8395731
• Product Code: PGW
• UDI-Device Identifier: 00763000588403
• UDI-Public: (01)00763000588403(17)260403(10)240403A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2024
• Report Date (Section F): 10/07/2024

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
• Device Model Number: 9735016
• Device Catalogue Number: 9735016
• Device Lot Number: 240403A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 190 KG
• Date Report Sent to FDA: 10/07/2024