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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 Problems Device Displays Incorrect Message (2591); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 08/28/2018
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 test the equipment. Testing revealed that it was determined that the monitor and computer required replacement. It was also noted that the primary and secondary video ports were found to be inverted. The system then passed the system checkout and was found to be fully functional. The monitor was returned to the manufacturer for analysis. Analysis found that the returned monitor displayed a good image when connected to a known good system. The monitor ran for over three hours with no issue. No fault was found. The computer has been returned to the manufacturer and is currently under analysis.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that the system randomly displayed ¿no input detected¿. No specific task was correlated with this system behavior. All of the cables were verified to be properly seated to the monitor, and to the back of the computer. This issue was discovered outside of a procedure and there was no patient present when this issue was identified.
 
Manufacturer Narrative
Initial reporter updated to proper value.
 
Manufacturer Narrative
The analysis of the computer for the navigation system was completed by medtronic personnel. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7886862
MDR Text Key120694923
Report Number1723170-2018-04789
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2008
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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