MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Codes	Human-Device Interface Problem (2949); Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9660651, serial/lot #: (b)(4).A medtronic representative went to the site to test and service the equipment.The navigation system passed the system checkout and performed as intended.The axiem unit was returned to medtronic for evaluation.The axiem was connected to a test system for twenty eight hours and all ports tracked consistently throughout the duration of testing.The reported issue was unable to be replicated.There was no failure found with the returned axiem unit.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported that when setting up the system, the axiem box booted to a fault light after being connected to the navigation system.There was no patient present when this issue was observed.A medtronic representative (rep) later reported that he was on site and noted that the axiem controller continued to show the fault light after being powered on for a couple of minutes.Upon further review of the emitter details, the rep saw that the details showed "high temperature" errors.The rep was able to confirm that the failure was with the controller and not the emitter as he was able to borrow a secondary axiem controller to use it with the original emitter and it did not have an issue.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8728767
• Report Number: 1723170-2019-03789
• Device Sequence Number: 11209555
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1