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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 Computer Software Problem (1112); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device udi not provided as this product is no longer manufactured. Manufacture date not available for this instrument at time of filing. A medtronic representative went to the site to test the equipment. Testing revealed that there was no response sometimes when using the software.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that ¿there is no response sometimes when using the software¿. This issue was noted outside of procedure and there was no patient present when this issue was observed.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. Correction: product and related fields updated to proper value.
 
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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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7597685
MDR Text Key111004471
Report Number1723170-2018-02751
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,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2009
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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