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

Model Number FUSION COMPACT

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that replacing the emitter did not restore functionality.The representative then replaced the electromagnetic interface box and the communication cable the emitter for the navigation system was returned to the manufacturer for analysis.The unit was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Event Description

Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the navigation system was experiencing difficulties tracking instruments.It was noted that the navigation system was restarted to temporarily restore functionality.After multiple restarts, the case could be completed as intended.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.

Manufacturer Narrative

The axiem was returned to the manufacturer for analysis.Analysis found that the issue could not be replicated.When connected to a test system with ent application registration, tracking and accuracy were normal on all ports.Connected and disconnected the tools from port and system remained normal.The axiem cable was returned to the manufacturer for analysis.Analysis found that the cable functioned normally without failure.Flexing the usb cables dies not indicate any intermittent opens.No fault found.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7679881
• MDR Text Key: 113746322
• Report Number: 1723170-2018-03348
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 65 YR
• Patient Weight: 82