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

Model Number 9733560XOM

Device Problem Human-Device Interface Problem (2949)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9731203, serial/lot #: (b)(4), udi#: (b)(4).A medtronic representative went to the site to perform a system check out and they replaced the emitter.The system functioned as intended.Fdm10, fdr120, fdc4307 are applicable to the system checkout.The electromagnetic field generator was returned for product analysis.The reported problem could not be duplicated.The field generator was connected to a test system for a burn-in test.The system remained in green status during all testing.Flexing the cable does not indicate any intermittent opens.No problem was found, the system was fully functional.Fdm10, fdr213, fdc67 are applicable to the product analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery.It was reported that there was difficulty verifying instruments.The manufacturer representative manipulated the instruments in the divot in order to proceed with verification.The site was then having issues tracking multiple instruments.The axiem box was establishing a connection and there was no issue in the emitter details.The representative had tried different trays of instruments and all showed the same issue.There was no patient harm and the procedure was not delayed over an hour.

• 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: 10001441
• MDR Text Key: 189246637
• Report Number: 1723170-2020-01303
• 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
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2020
• 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: 29 YR
• Patient Weight: 77