MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9732266, serial/lot #: unknown.No parts have been returned to medtronic for analysis.Device manufacturing date unavailable.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 sacroiliac and thoracolumbar procedure.It was reported that during the case the main cart monitor displayed no input and the surgeon monitor went black.The computer fan was not cycling.The medtronic representative who was present bypassed the video splitter and the software appeared on the surgeon monitor.The site continued with one monitor.There was no delay to the case, and there was no impact on patient outcome.It was later noted that the video splitter was replaced.
Additional Manufacturer Narrative
Device evaluation: a medtronic representative went to the site to test and service the equipment.The navigation system passed the system checkout and was performing as intended.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The video graphics array (vga) splitter was returned to the manufacturer for analysis.Functional testing and visual/physical examination was performed and no failure was found.The returned splitter displayed a good image for each port when connected to a known good system.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The splitter 9732266 4 port vga (b)(4) was returned for analysis.The returned splitter displayed a good image for each port when connected to a known good system.No problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8742772
• Report Number: 1723170-2019-03849
• Device Sequence Number: 16564046
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/03/2019

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: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/21/2019; 08/21/2019; 08/21/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/06/2019; 08/30/2019; 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 98