MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site staff was having difficulties transferring an exam over the network.In trouble-shooting, a medtronic representative walked the site through network configuration and their imaging department wanted to use dynamic host configuration protocol (dhcp).Subsequently confirmed the cable was plugged, however, no ip address was showing; confirmed set-up properly in dhcp and requested the site switch ports.Issue resolved, the site transferred exams successfully.The surgeon opted to continue the procedure following a 90 minute delay.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

A medtronic representative reported the site it department assigned an ip address that wasn't configured to the port the staff was using during this procedure.When they plugged the system into the correct port it worked properly.No parts have been returned to manufacturer for analysis.No further issues have been reported.

Manufacturer Narrative

System has been used at least 3 times since this issue occurred and is fully functional.Network transfers are working as expected.Per event summary switching to a different network port resolved the issue.Software is functioning as designed.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 4476423
• MDR Text Key: 5326829
• Report Number: 1723170-2015-00117
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• 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: 01/07/2015

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
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2012
• 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: 36 YR
• Patient Weight: 92