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 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Resolved at the time of event.

Event Description

A site representative reported that during functional endoscopic sinus surgery (fess), the software of the navigation system became unresponsive when attempting to delete patient scans that were not necessary for procedure.Site performed a ctrl+alt+delete to reset back out if system.After entering the system, the exams were present on the system.Site deleted one exam at a time and had no further issues.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No known impact on patient outcome.

Manufacturer Narrative

The software investigation was conducted through review of the system logs found that the reported event was related to a software issue.This issue was documented in a manufacturer software anomaly tracking database.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7422137
• MDR Text Key: 105207029
• Report Number: 1723170-2018-01578
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2012
• 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: 12 YR
• Patient Weight: 23