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

Model Number	9734060
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that this was not a software anomaly as there was a power surge in or which caused the communication error.Analysis found that the software functioned as designed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation system while outside of procedure.It was reported that the site had an issue where the software was displaying that the camera was not connected and all the tool cards were displayed as red.The system had no tracking issues during a case performed in the morning.Representative reported that the operating room (or) experienced an electric surge.Representative was unable to confirm if the camera displayed as disconnected before or after the surge.The ndi tool box configuration utility was checked on for the positioning sensor unit (psu) which indicated no failures.The event logs also did not show any errors.Representative confirmed that unplugging the system from the wall and replugging it fixed the issue.The navigation system was actively tracking an instrument.There was no patient present when the issue occurred.

• 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: 8648068
• Report Number: 1723170-2019-02735
• Device Sequence Number: 2212019
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1