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

Model Number	9734887XOM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tracker would not register instrument when placed in divot to begin tracking.Would only register instrument when placed above divot, making tracking inaccurate.If the inaccurate tracking were used patient harm would have potentially taken place.

• Brand Name: AXIEM¿
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 16102442
• Report Number: 16102442
• Device Sequence Number: 7673394
• Product Code: HAW
• UDI-Device Identifier: 00763000588380
• UDI-Public: (01)00763000588380(17)250727(10)2207281
• 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): 11/21/2022
• Report Date (Section F): 11/22/2022

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: 2207281
• 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: 01/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2023
• 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: Female
• Patient Race: White
• Date Report Sent to FDA: 11/22/2022