MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560XOM

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733808, serial/lot #: unknown.Initial reporter information was unavailable.A medtronic representative went to the site to test and service the equipment.It was noted that the dicom q/r was corrupt.The dicom q/r software was updated.The issue was resolved by installing the correct software on the system.The navigation system passed the system checkout and was found to be fully functional.A software analysis was also completed.It was determined that the behavior described is the intended behavior of the software.The software was functioning as designed.(b)(4).Device manufacturing date unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device.It was reported that the site was unable to load the standalone digital intercommunication of medicine (dicom) query retrieve (q/r) appliance on the system.When a medtronic representative (rep) tried to load dicom q/r, it went through the booting screen and eventually rebooted back to the application selection screen.It was noted that the system is running ear, nose & throat (ent) software that has its own embedded dicom q/r tool.There was no patient involved.

Manufacturer Narrative

Other relevant device(s) are: product id: 9733808 (software version: 1.1.5).Initial reporter information updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8796779
• MDR Text Key: 151278170
• Report Number: 1723170-2019-04110
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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