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

Model Number FUSION COMPACT

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.Patient weight not available from the site.A medtronic representative went to the site to test the equipment.It was reported that the navigation system was replaced.The navigation system was returned to the manufacturer for evaluation.Testing found that the monitor had spots on it that would move when the display was touched.It was reported that the navigation system became unresponsive on the registration page and exiting the application software.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A site representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system became unresponsive.It was reported that the issue occurred six times in the procedure.It saws reported that the issue repeated at the registration prompt each time.Manual adjustment of the navigation system and restarting the navigation system did not restore functionality.It was reported that the navigation system stayed on a blue screen for two minutes.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

An additional system checkout was performed and all tests passed.No parts required replacement.If information is provided in the future, a supplemental report will be issued.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7186663
• MDR Text Key: 97582682
• Report Number: 1723170-2018-00209
• 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,Followup
• Report Date: 06/02/2019

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
• Device Operator: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 06/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2016
• 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: 22 YR