MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

Later the same day another medtronic representative attempted to load the disk on the system.They were also unsuccessful.The error message would go away after pressing cancel, but return shortly after.This happened about 5-6 times.When the option to report problem was selected, the prompt for a password would show up.A replacement computer was sent to the site for issue resolution.On 6/26/2017 the medtronic rep reported that they were able to load the ent tools 7 on the compact and could not replicate the issue they were having before.All instruments performed without issue after tools cd was installed.Computer that was shipped was unopened and will be returned unused.

Event Description

A medtronic clinical specialist reported that when trying to load the tools 7 disk in the fusion compact t he system becomes unresponsive.She tried again while on the call, but the screen stated "system problem detected," and prompted her for a password.The screen went blank and the system rebooted itself.No patient present.

• 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: catherine eaton ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6692150
• MDR Text Key: 79249719
• Report Number: 1723170-2017-02831
• 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
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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