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 Erratic or Intermittent Display (1182)

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

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date is unavailable.A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue and the system was not showing any of the reported issue.The issue was has not occurred again.Representative reinstalled software as a precaution.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that during functional endoscopic sinus surgery (fess), the screen of the navigation system turned black when navigating.The system was rebooted but after rebooting the screen was flashing through configuration settings, starting and stopping and resetting.Rebooting the system with and without axiem box plugged did not resolve the issue.The procedure was completed without the navigation.There was no delay to procedure.No known impact on patient outcome.

Manufacturer Narrative

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

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7444045
• MDR Text Key: 105960833
• Report Number: 1723170-2018-01683
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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: Physician
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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
• Patient Age: 56 YR
• Patient Weight: 64