• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TRIA
Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Unstable (1667)
Patient Problem No Patient Involvement (2645)
Event Date 04/06/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. On (b)(6) 2016, a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. Touchscreen failure, no signal display in monitor. The medtronic representative fastened and re-connected the monitor cable. Issue resolved. System performed as intended. Return requested for suspect external cable. No parts were replaced. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A site physician reported that their navigation system intermittently has no signal display on the monitor. No further details regarding this issue, or specifically when it occurred, were provided. There was no patient present when this issue was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5632911
MDR Text Key44451885
Report Number1723170-2016-00721
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIA
Device Catalogue Number9730757
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-