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

Model Number FUSION

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment and was able to replicate the issue.The medtronic representative found the eminterface showed one "flt" and by removing the patient reference frame from the axiem box solved the issue.After which the emitter and axiem communication issue status changed from red to green, flt disappeared.The medtronic representative opted to replace the emitter (field generator) after which the hardware, software, and instruments passed the system checkout.The system was fully functional.No parts have been received by manufacturer for analysis.

Event Description

A site representative reported that, while in a functional endoscopic sinus surgery (fess) the site was unable to track the patient tracker or instruments.The emitter details showed a communication error.The site rebooted the system to resolve the issue.The surgeon completed the procedure with the use of the navigation system.There was a reported delay to the procedure of 10 minutes due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

Investigation of returned suspect field generator finds that the reported problem could not be duplicated.The field generator was connected to a test system for an overnight burn-in test.The system remained in green status during all testing.It passed the accuracy test with an error of 1.597mm.Flexing the cable does not indicate any intermittent opens.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6126354
• MDR Text Key: 60877777
• Report Number: 1723170-2016-05538
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K001284
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• 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: 33 YR
• Patient Weight: 37