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

Model Number FUSION

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Udi not available for this system at time of filing.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.The representative found the computer would reboot spontaneously.They replaced the box and the multi-out power supply.The navigation system then passed the system checkout and was found to be fully functional.The suspect integrated port, power supply enclosure assembly, field generator, fan, and internal cable were returned for evaluation.Analysis could not replicate the issue and there were no issues found.The suspect computer was returned for evaluation.Analysis confirmed the reported problem.After exiting the ear, nose & throat (ent) application, the display was black.Repeated rebooting, reseating modules and cards did not resolve the issue.The suspected issue is within the motherboard.A computer failure was confirmed.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the system was booting inconsistently, sometimes only booting the monitor or booting fully then shutting itself down.The system was used for a clinical case, but there was no patient involvement.Additional information received reported during troubleshooting, they changed the port the computer was plugged into on the isolation transformer.The site rebooted the system multiple times and entered different parts of the software, including admin screen, with no replication of the issue.They were going to the leave the system running inside the ear, nose & throat (ent) software for the next cases at the account and check back every 15 minutes or so.The following day, after switching the power position on the isolation transformer, they rebooted the system and left it on the select patient screen.After about 30 minutes, when the system was checked on, it had exited the software on its own.The representative on site tried to bypass the isolation transformer and connect the computer directly into the wall outlet, with no resolution.Further troubleshooting found that when only the mouse, monitor, and keyboard were plugged in, the system functioned normally.When the navigation box was connected, the issue reoccurred.The system speakers were noted to not be working, too.The box would be replaced.

Manufacturer Narrative

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

• 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: 7556975
• MDR Text Key: 109742835
• Report Number: 1723170-2018-02326
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169518452
• UDI-Public: 00643169518452
• 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

• 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: 05/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 07/03/2018
• 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