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

Model Number 9733560XOM

Device Problem Mechanical Problem (1384)

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

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9733467.Software version: 2.3.Patient information was unavailable from the site.No devices were returned to the manufacturer for analysis.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 used during an unknown procedure.It was reported that they are using this system and it has been exiting the software on its own.It's done it 2-3 times in the last 3 hours.Unknown delay and unknown impact to patient additional information received: type of surgical procedure is functional endoscopic sinus surgery (fess).There was a delay in procedure of less than 1 hour.There was no patient impact correlated with this event.

Manufacturer Narrative

Patient information provided.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.Testing revealed that the system was functioning as intended.The system then passed the system checkout and was found to be fully functional.Codes associated to the system: fdr, fdc.A software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to an anomaly in the medtronic navigation software anomaly tracking database.A software failure was confirmed.Codes associated with the software: fdr, fdc.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• 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: 9920464
• MDR Text Key: 186538441
• Report Number: 1723170-2020-01146
• Device Sequence Number: 1
• Product Code: PGW
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

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 Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2020
• 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: 66 YR
• Patient Weight: 66