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

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.

• Brand Name: STEALTHSTATION TRIA NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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 Key: 6136804
• MDR Text Key: 61207162
• Report Number: 1723170-2016-05469
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TRIA
• Device Catalogue Number: 9730759
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1