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

Model Number FUSION

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

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

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the emitter of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect emitter has been received by the manufacturer for evaluation.However, results are not available at this time.

Event Description

A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system became unresponsive while navigating a straight suction.It was reported that the navigation system was restarted and the representative was subsequently unable to verify instruments to re-register the patient.It was reported that the site brought in a second medtronic navigation system to complete the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Unique device identifier (udi) updated.Device manufacture date was updated.The field generator was returned to the manufacturer for analysis.The field generator was connected to a test system for eight hours and the reported problem could not be duplicated.All drives maintained an 'ok' status throughout testing.The system remained in green status during the duration of testing.Flexing the cable did not indicate any intermittent opens.

• 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: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7377915
• MDR Text Key: 103723959
• Report Number: 1723170-2018-01352
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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: 40 YR
• Patient Weight: 77