MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problems Display or Visual Feedback Problem (1184); Intermittent Communication Failure (4038)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could be replicated.To restore functionality, the navigation system was replaced.The navigation system was returned to the manufacturer for analysis.The system was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Event Description

Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the display on the monitor of the navigation system was described to be "fuzzy" with artifacts at start up.Restarting restored functionality temporarily as the issue would recur at the registration portion of the application software.Restarting eventually led to the navigation system not restarting.Following the procedure, when the issue was reported to medtronic, the navigation system was functioning as designed.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.No additional information was provided.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7886865
• MDR Text Key: 120694804
• Report Number: 1723170-2018-04796
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 71