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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 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
Onsite investigation was preformed and the field representative was able to replicate the issue, it was suspected that the video cable along with the power cable caused the reported event. Replacement of both aforementioned cables resolved the issue. No further issues were reported. Replaced cables were not returned to manufacturer for analysis, therefore, no findings are possible. A full system check-out was completed and all tests passed. Full system functionality was confirmed and the system was returned to service.
 
Event Description
A site representative reported that the navigation system's screen went black for around two seconds multiple times. There was no patient present when this issue was identified.
 
Manufacturer Narrative
The video cable, monitor power supply, and computer were returned to the manufacturer for analysis. All the components were found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
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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
amos jarrette
826 coal creek circle
attn:product quality experienc
louisville, CO 80027
7208902082
MDR Report Key6501444
MDR Text Key73095885
Report Number1723170-2017-01672
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2010
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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