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

Model Number	9734060
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient gender unavailable at the time of report.Other relevant device(s) are: product id: 9734137, serial/lot #: unknown; product id: 9734163, serial/lot #: unknown; product id: 9731861, serial/lot #: unknown.A medtronic representative went to the site to test the equipment.Testing revealed that there was a flickering issue with the monitor and there were 2 vga cables that were damaged inside the rack.The monitor and vga cables were replaced.The system then passed the system checkout and was found to be fully functional.The cable 9734163 vga m/f 4ft (lot# unknown) was returned for analysis.Analysis found that the returned cable was in good condition and passed a continuity test with no opens or shorts detected.No problem was found.The lcd 9734137 24in 1920x1200 touch i7 (lot# unknown) was returned but was still under analysis at the time of report.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 for a cranial resection procedure.The issue occurred intraoperatively and caused no delay to the surgery.It was reported that one of the navigation system's boom monitors was flickering.The site's other external monitor and medtronic monitors worked well.This did not affect the case since they had other monitors to look at.Technical services (ts) had the medtronic representative swap monitors and the working monitor worked with the other connections.The medtronic representative confirmed that the two vga cables were damaged where they meet and fell into the rack.The surgery was completed with navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
A hardware analysis was initiated to determine the probable cause of the issue.Analysis found and confirmed the allegation that the screen remained blank/black screen when powered on and showed no splash screen.If information is provided in the future, a supplemental report will be issued.

• 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: 8913026
• Report Number: 1723170-2019-04567
• Device Sequence Number: 13581792
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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 Expiration Date: 10/29/2012
• Device Model Number: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 107