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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problems Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 11/18/2016
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, all areas passed. System performed as intended. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A site clinical engineering representative reported that the site's navigation system shut-off unexpectedly. No further details regarding this issue, or specifically when it occurred, were provided. There was no patient present when this issue was identified.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE 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 Key6178501
MDR Text Key62537407
Report Number1723170-2016-05762
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
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 12/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
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 Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2004
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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