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 No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not made available from the site.Return requested.Replacement computer shipped to site 10/21/2016.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, after registering the patient the navigation system monitor went black and the power button was flashing.Re-booting the navigation system did not help.Ejected the cd that was in the drive and unplugged all cables except the power cable to the monitor.The monitor remained black and the power button continued to flash.The surgeon opted to discontinue the use of the navigation system and continued with another product.Delay in therapy was approximately 10 minutes.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier now provided.Patient age and patient weight now corrected.Investigation of returned suspect system finds that upon return the computer powered up and functioned as expected with a normal display.Was not able to replicate the reported failure at that time.The computer was then allowed to run continuously overnight.The next morning the display had areas of pixilation and was unresponsive.Cycling the power by unplugging the computer from ac did not resolve the issue.The computer did not power up and the power button flashed as reported.The reported issue was confirmed to be caused by an electrical failure of the monitor.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6113443
• MDR Text Key: 60436278
• Report Number: 1723170-2016-02983
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• 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: 01/03/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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: 75 YR
• Patient Weight: 95