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

Model Number	9733560XOM
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the system's internal cpu died.Once the computer was replaced, the system then passed the system checkout and was found to be fully functional.Computer was returned to medtronic but was not analyzed at the time of filing.Continuation concomitant oe medical products) product id : 9735146r.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that the system appeared to shutdown and then go into "no input detected" when trying to load a disc for a case.The site rebooted the system, but did not resolve the issue.There was no delay in the procedure and no impact on patient outcome.The cause was due to an internal cpu failure.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12085479
• Report Number: 1723170-2021-01718
• Device Sequence Number: 14328477
• Product Code: HAW
• UDI-Device Identifier: 00643169518452
• UDI-Public: 00643169518452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 81