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

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.

• 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: 5632911
• MDR Text Key: 44451885
• Report Number: 1723170-2016-00721
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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 Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TRIA
• Device Catalogue Number: 9730757
• 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 Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse