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

Model Number FUSION

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Environmental Compatibility Problem (2929)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to site to test the equipment.Representative was able to replicate the reported issue as the system displayed "no input detected" message and fan cycling sound could be heard.Rebooting the system did not resolve the issue.Representative reported that a computer was replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has been received by the manufacturer for evaluation.The computer was tested and the issue was confirmed as the computer was power cycling.

Event Description

A medtronic representative reported that during functional endoscopic sinus surgery (fess),the navigation system unexpectedly shut down and booted up with "no input detected".Rebooting the system resolved the issue temporarily and site proceeded with surgery.The procedure was completed with the use of navigation.No information was provided on delay to procedure.No known impact on patient outcome.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information: patient demographics provided.The surgeon opted to complete the procedure without the use of the navigation system.There was no reported impact on patient outcome.Correction: event date updated to proper value.

Manufacturer Narrative

The fda codes were updated to reflect current coding guidelines.If information is provided in the future, a supplemental report will be issued.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7223177
• MDR Text Key: 98436046
• Report Number: 1723170-2018-00400
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 03/27/2018; 03/27/2018
• Supplement Dates FDA Received: 02/19/2018; 04/10/2018; 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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: 41 YR
• Patient Weight: 93