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

Model Number 9733560XOM

Device Problem Output Problem (3005)

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

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 9733467, version: (b)(4).Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the system was getting a red status for the electromagnetic localization box and emitter.The system was rebooted several times which resolved the issue.The site was getting green status but then it switched to red while in the register screen.While the manufacturing representative began setting up another navigation system to use, the status switched back to green on the original system.There was a less than 1 hour delay to the procedure and no impact to patient outcome as a result of this issue.

Manufacturer Narrative

A software analysis was initiated.Analysis found that the issue was unrelated to the software of the navigation system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the axiem emitter of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.Previous codes still apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information provided.Additional information) section d information references the main component of the system and other applicable components are: product id: 9733320, serial/lot #: (b)(4); product id: 9731203, serial/lot #: unknown a medtronic representative went to the site to test the equipment.It was reported that the manufacturing representative replaced the electromagnetic localization box.It was noted that the site was able to use the system for two cases but the same issue then resurfaced.At a later site visit, the manufacturing replaced the emitter and the communication was restored.The system then performed as intended.The electromagnetic localization box was returned to medtronic for analysis.Analysis revealed there were no issues with the electro magnetic localization box.The issue could not be duplicated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.After replacing the electromagnetic localization box, the site was able to use the system for two cases but the same issue then resurfaced.

Manufacturer Narrative

The emitter with lot number 0400002570 was returned to medtronic for analysis.Analysis revealed that the emitter/field generator would not track and displayed a red status.There was a fault on coil five.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other applicable components are: product id: 9733320r, serial/lot #: unknown, ubd: unknown, udi# unknown.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: 9354325
• MDR Text Key: 178347111
• Report Number: 1723170-2019-05708
• Device Sequence Number: 1
• Product Code: HAW
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• 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
• Patient Age: 63 YR
• Patient Weight: 75