MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9733560XOMR
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9731203, serial/lot #: unknown.A medtronic representative went to the site to test the equipment.The navigation system passed the system checkout and was found to be fully functional.No parts were replaced on the system.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 functional endoscopic sinus surgery (fess).It was reported that the site was having issues tracking instruments.A medtronic representative (rep) was on site and noted that the emitter placement was not optimal.The emitter was about 2 feet away from the patient.The rep suggested moving the emitter.After the emitter was moved, the issue was resolved.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

• Brand Name: FUSION NAVIGATION SYSTEM
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8791923
• Report Number: 1723170-2019-04099
• Device Sequence Number: 1993374
• Product Code: PGW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 09/14/2013
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR