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

Model Number	9733560XOMR
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9736119r, serial/lot #: unknown, ubd: unknown, udi#: unknown.No parts have been received by the manufacturer for evaluation.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 the system was experiencing issues with the monitor freezing.A manufacturer representative went on-site and checked out the system.It was noted that when turning on the system, it worked fine.The representative went into the patient information and that checked out.When they went back in the software, they noted that the mouse stopped working, the screen froze, and the monitor went blank stating "no video input".The representative turned the system on and off again and the system booted up after a brief moment.It was noted that troubleshooting included re-seating the cables, checking the cables for damage, and restarting the system.There was no patient present when this issue was identified.

• Brand Name: IGS ENT SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8693754
• Report Number: 1723170-2019-03254
• Device Sequence Number: 11266891
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 01/21/2013
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: N01724537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1