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

Model Number	9733856R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during preventative maintenance the system became unresponsive.The manufacture representative restarted the system and it stated no video signal and the computer fan stayed on for 15 seconds and then turn off.He did a hard reboot of the system and the issue persisted.He did another hard reboot and system booted up as expected.Technical services (ts) requested he do a shutdown through the software and he was unable to replicate issue.There was no patient present.

• Brand Name: STEALTHSTATION NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8429583
• Report Number: 1723170-2019-01172
• Device Sequence Number: 3026402
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1