MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.

Event Description

Information was received from the site regarding a navigation system use during a functional endoscopic sinus surgery (fess) procedure.It was reported that the software will jump back to the registration screen while they are navigating.The first registration is not saved and they have to re-register the patient.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information available.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the computer of the navigation system was returned to the manufacturer for evaluation.The system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7447012
• MDR Text Key: 106147040
• Report Number: 1723170-2018-01701
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169504394
• UDI-Public: 00643169504394
• 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
• Report Date: 06/15/2018

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: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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