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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 Erratic or Intermittent Display (1182); Device Stops Intermittently (1599); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative was unable to replicate the reported issue. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. No parts were replaced. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of procedure, the monitor of the navigation system would intermittently flicker black for a moment. There was no patient present at the time of the issue.
 
Manufacturer Narrative
A dvi to hdmi cable was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
Device code was corrected. 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
7208902515
MDR Report Key7329368
MDR Text Key102078000
Report Number1723170-2018-01097
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,Followup,Followup
Report Date 06/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
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 Manufacturer03/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2010
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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