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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 Unstable (1667); Material Deformation (2976); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative, following-up at the site, reported the navigation system power comm cable was exchanged and the issue was resolved. The medtronic representative was able to reproduce the issue and identified the cable as defective (lose connection). Return requested for suspect power comm cable. No parts have been received by manufacturer for analysis. On 05/23/2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. Return requested for comm power cable. No further issues have been reported.
 
Event Description
A medtronic representative received a report from a site that their navigation system camera suddenly lost connection. The site moved the power/comm cable and the connection came back. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Medtronic investigation of returned suspect power comm cable finds that there is an open in the communication cable. Pin 7 on the fischer connector side is broken but was held together with heat shrink, thus the intermittent communication. The reported issue was confirmed to be caused by an electrical failure. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key5727582
MDR Text Key47497433
Report Number1723170-2016-01079
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAU
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,Followup
Report Date 08/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2005
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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