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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION COMPACT
Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/24/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to replace the equipment. Replaced the navigation system's computer. The navigation system then was found to be fully functional. Issue resolved with part replacement. The compact computer was returned to the manufacturer for analysis. Investigation was unable to duplicate reported issue. The returned computer was found to have normal function. Was able to load several exams without issue. Was able to move forward and backward within the procedure without the computer becoming unresponsive. No problem or failure found.
 
Event Description
A medtronic representative reported the navigation system software was regularly becoming unresponsive. He noted that if double clicking a procedure instead of selecting the procedure, then hitting the arrow forward button, the system would become unresponsive and would have to reboot. He also reported that he would have to hit the arrow forward/back button several times and wait before it would eventually move. The system was unresponsive several times during the course of the call with technical services (ts) and had to be rebooted. There were only three patient exams on the system. There was no patient present when this issue was identified.
 
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Brand NameMEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
Type of DeviceEAR NOSE AND THROAT 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
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6509215
MDR Text Key73343483
Report Number1723170-2017-01744
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
Number of Events Reported1
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
Report Date 04/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberFUSION COMPACT
Device Catalogue Number9735602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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