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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 Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
Patient age not available from the site. A medtronic representative went to the site to test the equipment. The computer was replaced. The navigation system then passed the system checkout and was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information that during a functional endoscopic sinus surgery (fess) case the monitor unexpectedly went black. After rebooting the system the black monitor went away. It was noted this is not the first time this has happened and that sometimes when the site moves the mouse around the monitor will come back on. In the past when the rep has taken a look at the system he cannot replicate the issue. There was no reported impact on patient outcome.
 
Manufacturer Narrative
The power supply for the navigation system was returned to the manufacturer for analysis. The power supply was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The monitor was returned to the manufacturer for analysis. The monitor was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
Additional information: medtronic received additional information that the other dates and times were not provided. It was just reported from the surgeon that the issue had occurred before.
 
Event Description
Medtronic received information that during a functional endoscopic sinus surgery (fess) case the monitor unexpectedly went black. After rebooting the system the black monitor went away. It was noted this is not the first time this has happened and that sometimes when the site moves the mouse around the monitor will come back on. In the past when the rep has taken a look at the system he cannot replicate the issue. There was no reported 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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7565839
MDR Text Key109947366
Report Number1723170-2018-02453
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,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2010
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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