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

Model Number FUSION

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went to the site to test the equipment.The cables were checked and connection to the monitor.The system was powered on but the monitor was not responding.It was attempted to power switch on the back of the monitor and was able to get images.A restart was attempted but the monitor failed to respond.The original monitor had no vga connection, so it was unable to be tested.The cables and monitor were replaced and the issue resolved.The navigation system then passed the system checkout and was found to be fully functional.The lcd was returned to the manufacturer for analysis.Analysis found that the monitor remained working during testing.However, the power supply that came with the monitor was plugged in the monitor and after burning in for 30 minutes, the power supply had no output voltage.The monitor turned off.Analysis found that the reported event was related to an electrical issue.Device manufacturing date is unavailable.

Event Description

Medtronic received information regarding a navigation system.It was reported that during a case, the system monitor would not turn on, but the fans were running and the mouse was on.The site reported that they had the system on in another room to enter the patient information and then they turned the system off and moved it to the operating room (or).Once in the or, the monitor never came back on.The site tried another outlet in the or, tried rebooting the system, and tried reseating the cables at the back of the monitor but the issue did not resolve.There was no patient present when this issue was identified.Additional information received almost a week later reported the site was able to use the navigation system with a new monitor to finish the case.

Manufacturer Narrative

Additional information: device manufacture date provided.

• 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: 7632841
• MDR Text Key: 112187551
• Report Number: 1723170-2018-02945
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2009
• 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