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

Model Number FUSION

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi and manufacture date not available for this probe at time of filing.A medtronic representative went to the site to test the equipment.The imaging device failed the hardware test but passed the software and instrument tests.The computer, fan, emitter and axiem cable were all replaced.The imaging system then passed the system checkout and was found to be fully functional.The computer, fan and cable were returned to the manufacturer for analysis however, analysis results are not yet available.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the system was booted, the ent software was accessed, the select patient was displayed and within ten minutes, the screen went black and the system was unresponsive.The manufacturer representative had to hard power the system off.Upon starting the system, it did not boot to the select software screen.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.Analysis found that initial and subsequent boot and navigation of ent was good.Upon exiting the application the second time, the computer was still running but the display was black.After repeated reboots, it was noted that the computer would not post.Reseating all the ram modules, graphics card and capture card did not resolve the issue.Replacing the ram did not resolve the issue.Suspected motherboard malfunction.Analysis found that the reported event was related to a computer component issue.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.The fan was returned to the manufacturer for analysis.Analysis found that the fan powered on and functioned without any issue.No fault found.The axiem internal cable was returned to the manufacturer for analysis.Analysis found that the cable was in good physical condition with no apparent damage.It passed continuity tests with no opens or shorts.No fault found.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7573154
• MDR Text Key: 110202011
• Report Number: 1723170-2018-02542
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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