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 Patient Involvement (2645)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went to the site to test the equipment.Testing revealed that the computer of the navigation system was replaced to restore functionality as the reported issue could be replicated while testing.The system then passed the system checkout and was found to be fully functional.The computer has not been received by the manufacturer for evaluation.

Event Description

A manufacturer representative reported that, while outside of a procedure, the navigation system became unresponsive and exited from the application software without prompt from the user.It was reported the representative could re-enter the application software.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Additional information: a review of the logs from the system did not provide any additional information on the cause of the reported issue.

Manufacturer Narrative

The computer for the navigation system 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.A software analysis was initiated to determine the probable cause of the issue through known anomaly determination.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 ; 7635267745
• MDR Report Key: 7422588
• MDR Text Key: 105203656
• Report Number: 1723170-2018-01600
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2018

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: 04/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 05/16/2018
• Supplement Dates FDA Received: 05/14/2018; 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2010
• 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