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

Model Number	9734062
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the power cord for the navigation interface unit (niu) was unplugged.The power cord was plugged in, and the issue resolved.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 being used for a sacroiliac and thoracolumbar procedure.It was reported that pre-operatively, the system displayed "localizer not connected".The system was restarted four times without resolve.The site used a different navigation system to continue the case.There was no reported impact to patient outcome and there was no surgical delay.
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Additional information/review determined that the cause of the event was traced to the user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that there was no patient involved with the case.The system was booted in the morning with no patient presence.It was noted that the cause of the issue was that the niu control box was unplugged.The sites biomed was made aware and it was noted that the boom had been moved and the control box unplugged.The site used another navigation system for the case that occurred that day.

• Brand Name: STEALTHSTATION I7 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8290087
• Report Number: 1723170-2019-00460
• Device Sequence Number: 13941415
• Product Code: HAW
• UDI-Device Identifier: 00613994665928
• UDI-Public: 00613994665928
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 9734062
• Device Catalogue Number: 9734062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1