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

Model Number 9733560XOM

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Udi not available for this system at time of filing.Concomitant medical products: other relevant device(s) are: product id: 9731203, serial/lot #: unknown, ubd: unknown, udi#: unknown.No parts have been received by the manufacturer for evaluation.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.It was reported that the emitter was not tracking while testing.Then it would track intermittently when testing the system with various ports and different instrument trackers in a controlled environment.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: lot number of product id: 9731203 is 0400001235.A medtronic representative went to the site to test the equipment.Testing revealed that parts were replaced.The system then passed the system checkout and was found to be fully functional.The field generator was returned to the manufacturer for analysis.Analysis found that the reported issue could not be duplicated.The field generator was connected to a test system for an overnight burn-in test.The system remained in green status during all testing.Flexing the cable did not indicate any intermittent opens.No failure was found.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: 9334791
• MDR Text Key: 178153116
• Report Number: 1723170-2019-05642
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/10/2020
• 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