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

Model Number 9733560XOM

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9736119r, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system became unresponsive twice.The system was hard rebooted and the system booted into a grub menu that displayed, 'grub menu, please wait." the representative attempted to press escape and the issue did not resolve.

Manufacturer Narrative

Serial number of concomitant medical products is: (b)(4).Additional information) a medtronic representative went to the site to test the system at the time of the reported event.Rebooting the system resolved the issue.The system performed as intended and no parts were replaced.The system then passed a system checkout.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.Rebooting the computer resolved the issue and there have been no more issues since.

• 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: 9921008
• MDR Text Key: 186325876
• Report Number: 1723170-2020-01149
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2012
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• 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