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

Model Number FUSION

Device Problems No Display/Image (1183); Mechanical Problem (1384); Device Stops Intermittently (1599); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.It was reported that the computer of the navigation system was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that, while outside of a procedure, the navigation system displayed that there was no input detected without prompt from the user.It was reported that the interface box displayed an error message and that the emitter was not emitting.Restarting the navigation system temporarily restored functionality, but the reported issue reoccurred after a few minutes.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

The computer was returned to the manufacturer for evaluation.After functional testing, performance testing, visual and physical examination no fault was found.There was no hard disk drive (hdd) or ram errors reported.After 72 hours of bench testing there were no video faults encountered.The system passed all system tests and requirements.

Manufacturer Narrative

Device code was corrected.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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7270757
• MDR Text Key: 100127666
• Report Number: 1723170-2018-00705
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• 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