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

Model Number	9734887
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of pseudotumor cerebri.Procedure: craniotomy stereotactic ventriculoperitoneal, right occipital peritoneal shunt revision.The medtronic navigation non-invasive patient tracker did not originally work when plugged into the stealth machine.When it was unplugged and re-plugged back in it worked.Midway through the procedure, the tracker stopped working and would not restart.No known harm to patient at this time.

• Brand Name: AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 19285285
• Report Number: 19285285
• Device Sequence Number: 12880043
• Product Code: HAW
• UDI-Device Identifier: 00763000588373
• UDI-Public: (01)00763000588373(17)250131(10)220201A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/23/2024
• Report Date (Section F): 04/23/2024

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: 9734887
• Device Lot Number: 220201A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Date Report Sent to FDA: 04/23/2024