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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TRIA
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2016
Event Type  malfunction  
Manufacturer Narrative
Site dr. (b)(6) declined to provide patient information. Return requested for suspect cpu on (b)(6) 2016. No parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative reported that, while in a procedure, the site's navigation system unexpectedly became unresponsive during patient registration. In trouble-shooting, shutting down the navigation system and re-starting did not resolve the issue. Confirmed electricity in monitor and computer, however, nothing indicated on the monitor screen. The navigation system was powered off once and the computer was checked. The cover of the computer was opened and graphic board was re-plugged. When the computer was then powered on, indications on the monitor screen were confirmed. It was deemed likely that the graphic board was worn out. The surgeon opted to continue and completed the procedure without the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.
 
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Brand NameSTEALTHSTATION TRIA 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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6136804
MDR Text Key61207162
Report Number1723170-2016-05469
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIA
Device Catalogue Number9730759
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2010
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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