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

Model Number FUSION

Device Problems No Device Output (1435); Device Stops Intermittently (1599)

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.The power supply cable was returned to the manufacturer for analysis.The power supply cable was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The suspect part lcd monitor was returned to the manufacturer for evaluation.However, results are not available at this time.A manufacturer representative went to the site to test the equipment.The lcd monitor and power supply cable for the monitor were replaced.The navigation system then passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the site was having recurring issues of the monitor shutting off during cases.After about an hour of usage, the monitor would shut off for 5-10 seconds, then turn itself back on and return to the same spot in the software.A small blue message box would appear in the center of the screen when the issue occurred.The manufacturer representative was able to replicate the issue after leaving the system on for an hour.There was no patient present when this issue was identified.Additional information received later the same day reported after the monitor would shut off, the site would continue to use the system.It was noted sometimes just moving the mouse would wake the screen back up.Other times, they had to turn the machine off and back on.It was unknown if the issue recurred after it would turn back on.

Manufacturer Narrative

The power supply for the monitor of the navigation system was returned to the manufacturer for analysis.The power supply was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The monitor for the navigation system was returned to the manufacturer for analysis.The monitor was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: 7572232
• MDR Text Key: 110169919
• Report Number: 1723170-2018-02509
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1