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 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Udi and device manufacture date not available at the time of this report.A medtronic representative went to the site to test the equipment.The rep gathered logs and patient archive.The rep was unable to replicate the reported event.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A site representative reported via a manufacturer representative that the navigation system unexpectedly exited during the middle of a functional endoscopic sinus surgery (fess) procedure.The system was rebooted and required the surgeon to re-register the patient.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact to the outcome of the patient.

Manufacturer Narrative

Additional information: udi number and device manufacture date have been received and the fields updated with the new information.The software investigation found that the reported event was related to a software issue.This issue was documented in a software anomaly tracking database.

Manufacturer Narrative

The power supply for the monitor of the navigation system was returned to the manufacturer for analysis.The power supply was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The monitor for the navigation system was returned to the manufacturer for analysis.The monitor 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 ; 7635267745
• MDR Report Key: 7405729
• MDR Text Key: 104821267
• Report Number: 1723170-2018-01515
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/07/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 06/05/2018
• Supplement Dates FDA Received: 05/14/2018; 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2010
• 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: 30 YR
• Patient Weight: 57