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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 07/04/2018
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 the power cord from the personal computer (pc) was loose. The issue was resolved by plugging the cable in all the way. The system then passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. It was reported that sometimes, the screen was black and importing data with a cd was not possible. No patient present.
 
Manufacturer Narrative
Manufacturer updated to proper value.
 
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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 Key7718183
MDR Text Key114974220
Report Number1723170-2018-03693
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2009
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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