MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.

Event Description

A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system was unable to track instruments.It was reported that the interface box of the navigation system would not communicate.Restarting the navigation system did not resolve the reported issue.It was noted that after disconnecting the emitter, the navigation system displayed that the localizer was not connected.Once switching the universal serial bus (usb) port being used on the navigation system, functionality was restored.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Correction: unique device identification (udi) and device manufacture date updated to proper value.

Manufacturer Narrative

Patient information was unavailable from the site.

Event Description

Medtronic received information regarding a navigation device being used intra-operatively for a functional endoscopic sinus surgery (fess) procedure.It was reported that the navigation device was not tracking any instruments.The emitter details pane stated the box was no communicating.There was a reported delay to the procedure of less than 1-hour and no known impact on the patient outcome.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT 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: 7283101
• MDR Text Key: 100660198
• Report Number: 1723170-2018-00772
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

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: Health Professional
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 08/14/2018
• Supplement Dates FDA Received: 03/09/2018; 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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