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 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic representative went to the site to test the system and reported that the site had been using fusion for more cases with no issues.Part not returned for evaluation.

Event Description

Medtronic received information regarding a navigation system during a functional endoscopic sinus surgery (fess) procedure.It was reported that the exams were already loaded and during registration, the system became unresponsive.After rebooting, the system seemed to function normally and about 3 hours into the case it became unresponsive again during navigation.The mouse was unresponsive as well.The surgery was completed successfully with the use of navigation and the delay was less than an hour.There was no known patient impact.

Manufacturer Narrative

Correction: a medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7620254
• MDR Text Key: 111702352
• Report Number: 1723170-2018-02892
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 09/05/2018; 09/19/2018
• Supplement Dates FDA Received: 09/10/2018; 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2008
• 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: 18 YR
• Patient Weight: 45