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

Model Number	9735602
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 outside of a procedure.It was reported that the axiem box was not communicating with the navigation system.The axiem box had an 8 on the back.There was signal that there was no communication.The emitter details also states no communication and prompts to reboot the system.The axiem and the navigation system were rebooted while changing the connection order and which usb port the axiem box was connected to but the issue did not resolve.There was no patient present at the time of the event.The representative noted that there is likely a short in the cable connecting the axiem.It worked when the representative turning on the system, however the site states at times when they move the tripod it will lose connection.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated in three procedures.However, as a precaution, the electromagnetic communication cable was replaced as a precaution.The system then passed the system checkout and was found to be fully functional.The cable was returned to the manufacturer for analysis.The cable was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• 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: 8815706
• Report Number: 1723170-2019-04180
• Device Sequence Number: 3205623
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153247
• 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,Followup
• Report Date (Section B): 08/15/2019

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 Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1