MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. AXIEM¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733533XOM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Did not register instrument.

• Brand Name: AXIEM¿
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 19229451
• Report Number: 19229451
• Device Sequence Number: 14869195
• Product Code: HAW
• UDI-Device Identifier: 00763000588342
• UDI-Public: (01)00763000588342(17)250521(10)230522A
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 11/30/2023
• Report Date (Section F): 12/11/2023

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: 9733533XOM
• Device Lot Number: 230522A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 12/11/2023