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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 Consequences Or Impact To Patient (2199)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to site to test the equipment. Representative reported that the system functionality was restored temporarily by unplugging and replugging the cables. Representative was able to power on the system and boot up to application page. But when navigating through software monitor displayed blank again. When powering down the system and powering it up again, the system would not power back on. It was conformed that the computer was receiving power and tightening the cords at the back of monitor did not resolve the issue. Representative replaced monitor, cables and power supply unit. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect computer has been received by manufacturer for evaluation. When the returned monitor was connected to a known good system, the monitor display was working without any issues and displayed good images. The monitor was allowed to run for extended period of time and did not display the reported behavior. No fault found.
 
Event Description
A medtronic representative reported on behalf of sit that during a functional endoscopic sinus surgery (fess), while performing a registration the monitor of the navigation system displayed black. Representative suggested site to reboot the system, but the site was unable to reboot. The procedure was completed without the use of navigation. There was a delay of less than 1 hour. No impact on patient outcome.
 
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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
prashanth gali
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6969627
MDR Text Key90436574
Report Number1723170-2017-04291
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 10/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2007
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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