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

Model Number	9734685
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the issue was confirmed.The axiem box was then replaced.The system then passed the system checkout and was found to be fully functional.The axiem was returned to the manufacturer for analysis.Analysis found that there was a communication error when hooking up the axiem box with a known system.Analysis found that the reported event was related to an electrical issue.Product analysis (b)(4).Mnav findings and conclusions: reported problem was confirmed.The axiem unit was connected to a test system with the ent application.Test system reported that the axiem box, and emitter was showing a communication error.Eminterface reported a fault on coils one, two, and three.Mnav methodology: functional testing;visual/physical examination.Mnav detail: awaiting field response/info.Mnav usability: false.Mnav able to duplicate the issue?: yes.Mnav bai/oobf?: false.Mnav failure mode: electrical.Mnav failure mechanism: red status/no tracking.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that when setting up for the case, the axiem box was not working correctly.In the emitter details and everything was red indicating no communication.No patient was present at the time of the event.

• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8039133
• Report Number: 1723170-2018-05501
• Device Sequence Number: 1302751
• Product Code: HAW
• UDI-Device Identifier: 00643169505827
• UDI-Public: 00643169505827
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: No Information
• Device Model Number: 9734685
• Device Catalogue Number: 9734685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1