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 Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative was able to replicate the reported issue with multiple patient exams and confirmed that other system were functioning without issue.No information regarding resolution has been provided.No parts were replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of procedure, the navigation system would intermittently become unresponsive and had to be rebooted manually.Uninstalling and reinstalling the software did not resolve the issue.There was no patient present at the time of the issue.

Manufacturer Narrative

Correction: device manufacture date updated to proper value.While testing the navigation system, it was reported that the computer for the navigation system was replaced.The computer for the navigation system was returned to the manufacturer for analysis.The device 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7204040
• MDR Text Key: 97951842
• Report Number: 1723170-2018-00292
• 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
• Report Date: 02/12/2018

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: 01/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• 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