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 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Axiem system was returned to the manufacturer for analysis.Analysis found that when the axiem was connected to a test system, it was functioning correctly.The hardware investigation found that the reported event was related to a hardware issue.Manufacture date was unavailable.

Event Description

Medtronic received information regarding a navigation system during a functional endoscopic sinus surgery (fess).It was reported that the system was not communicating with the axiem box.The system was displaying the red 8 on the side.Both systems were rebooted and reseated to each other with no resolution the system still displaying the red 8.Navigation and medtronic imaging was aborted but replacing the axiem box resolved the issue.The surgery was completed with less than an hour delay and no patient impact.

Manufacturer Narrative

Additional information: manufacture date.

• 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: jonathan wong ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7635267745
• MDR Report Key: 7895847
• MDR Text Key: 120968731
• Report Number: 1723170-2018-04825
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• 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: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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
• Patient Age: 51 YR
• Patient Weight: 52