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

Model Number FUSION

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.On 10/14/2015 a site representative, materials management or, reported that he was unable to pinpoint where the smoke was coming from.He was smelling something electrical burning.Issue was noticed prior to using the navigation system for surgery.On 10/14/2015 in trouble-shooting at the site, a medtronic representative reported the navigation system was no longer smoking and when plugged it in, the system powered on.The monitor displayed "no input" and the fan on the computer was not working.Checked the power outputs on the isolation transformer and they all function and the computer is the only part that is not powering on.Attempted power cycling the navigation system a few times and that did not resolve the issue.Return requested.Replacement computer shipped to site 10/15/2015.Medtronic investigation of returned suspect computer finds that the computer did not power on.Green light comes on, however, no fans or other sign of power.Power supply smells burnt.Suspect malfunctioning power supply.Computer failure.No or low voltage/power supply malfunction.Hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.On 10/16/2015 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.The computer was smoking following a procedure.The navigation system over-heated and started smoking.Installed new computer and the system booted and work as it should.Issue resolved.System performed as intended.No further issues have been reported.

Event Description

A medtronic representative received a report from a site that their navigation system is smoking from the side of the computer.No further details regarding the issue, or where it was when this occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

Correction to serial number and device manufacture date provided.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5214893
• MDR Text Key: 30970839
• Report Number: 1723170-2015-01372
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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