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 Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) is unavailable.The portable axiem system was returned to the manufacturer for evaluation.It was reported the alleged issue was confirmed.The axiem unit was connected to a test system with the ent application.Test system reported the axiem box and emitter were showing a communication error.The eminter face reported a fault on coils 1, 2, and 3.Device manufacturing date is unavailable.

Event Description

Medtronic received information regarding a navigation system.It was reported that when a manufacturer representative plugged in the emitter, there was an emitter and axiem communication error.It was reported that when the emitter was disconnected, the axiem had green communication.The representative rebooted the system while the emitter was disconnected from the axiem box, but this did not resolve the issue.This issue was discovered outside of a procedure and there was no patient present when this issue was observed.

Manufacturer Narrative

Correction: product and related fields 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7541933
• MDR Text Key: 109180371
• Report Number: 1723170-2018-02258
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 06/11/2018
• 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