MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.

Event Description

Information was received regarding a navigation system issue that occurred during a functional endoscopic sinus surgery (fess).It was reported that while navigating the system became unresponsive.The surgeon knew it was not responding because the endoscope video was not recording.To troubleshoot the cover was taken off and the box was showing "8".The system was unplugged and plugged back in and still showed 8.The emitter interface was checked and listed as ok.The manufacturing representative tried replicating the issue and the system became unresponsive again and was displaying "7".They rebooted to resolve the issue.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.No further information was provided.

Manufacturer Narrative

Additional information: additional information received approximately a month later reported during troubleshooting, the emitter was disconnected from the axiem box and disconnected the video input from the endoscope into the navigation system, but the system remained unresponsive.The system would only work following a hard shutdown and restarting.It was noted this issue was only identified with one out of the two navigation system the site had.On (b)(6), it was identified the video/camera used with the navigation system was made by another manufacturer.Information received a week later reported the unit had become unresponsive in surgeries with and without use of the video/camera.Approximately two weeks later, it was noted that the unresponsive behavior had not been able to be replicated.It was indicated no other devices were connected at the time of unresponsiveness except a video hub for the video/camera via s-video or composite.The logs for the navigation system were reviewed by medtronic personnel.The logs indicated there was a video service failure.However, there was no additional insight into the probable cause in relation to the axiem and no additional insight into the cause of the video service failure.

Manufacturer Narrative

Four parts were received by the manufacturer and analysis was completed.The i/o hub was returned to the manufacturer.Functional testing found that the component had no issues and performed within specifications.The power supply was returned to the manufacturer.Functional testing found that the component had no issues and performed within specifications.The power cable was returned to the manufacturer.Functional testing found that the component had no issues and performed within specifications.The usb - a to b converter was returned to the manufacturer.Functional testing found that the component had no issues and performed within specifications.

Manufacturer Narrative

The electromagnetic integration box was returned to the manufacturer for analysis.The unit was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The emitter for the navigation system was returned to the manufacturer for analysis.The emitter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The electromagnetic interface communication 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.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the power cable, in/out assembly and power cable assembly were replaced.The system then passed the system checkout and was found to be fully functional.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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: 7469983
• MDR Text Key: 106798816
• Report Number: 1723170-2018-01795
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2009
• 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: 33 YR
• Patient Weight: 68