MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Human-Device Interface Problem (2949)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Udi not available for this system at time of filing.System not evaluated as issue was resolved by reseating and cleaning cable.Device manufacturing date not available at time of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported a message appeared that there was no magnetic field emitted.The cable between the axiem controller box and the monitor was not connected.After the cable was connected and the system was restarted, the orange line did not change to green in the setup equipment screen, and it was noted the number on the back of the axiem controller box was ¿1¿.The usb and the port were wiped with an alcohol swap and the system was rebooted with resolve.There was no further issue.This use occurred preoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.

Manufacturer Narrative

The cable was returned to the manufacturer for analysis.Analysis found that there were no issues with the returned cable.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The computer of the navigation system was returned without any accessories and was found to power up and connected with a known good axiem without issue.No issues were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• 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: 8147557
• MDR Text Key: 129930958
• Report Number: 1723170-2018-06163
• Device Sequence Number: 1
• Product Code: PGW
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

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: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 07/16/2019; 07/30/2019
• Supplement Dates FDA Received: 07/16/2019; 08/21/2019
• 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: Unknown
• Patient Sequence Number: 1