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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 05/29/2018
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. The cables were checked and connection to the monitor. The system was powered on but the monitor was not responding. It was attempted to power switch on the back of the monitor and was able to get images. A restart was attempted but the monitor failed to respond. The original monitor had no vga connection, so it was unable to be tested. The cables and monitor were replaced and the issue resolved. The navigation system then passed the system checkout and was found to be fully functional. The lcd was returned to the manufacturer for analysis. Analysis found that the monitor remained working during testing. However, the power supply that came with the monitor was plugged in the monitor and after burning in for 30 minutes, the power supply had no output voltage. The monitor turned off. Analysis found that the reported event was related to an electrical issue. Device manufacturing date is unavailable.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that during a case, the system monitor would not turn on, but the fans were running and the mouse was on. The site reported that they had the system on in another room to enter the patient information and then they turned the system off and moved it to the operating room (or). Once in the or, the monitor never came back on. The site tried another outlet in the or, tried rebooting the system, and tried reseating the cables at the back of the monitor but the issue did not resolve. There was no patient present when this issue was identified. Additional information received almost a week later reported the site was able to use the navigation system with a new monitor to finish the case.
 
Manufacturer Narrative
Additional information: device manufacture date provided.
 
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Brand NameFUSION NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL 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
MDR Report Key7632841
MDR Text Key112187551
Report Number1723170-2018-02945
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOMR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2009
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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