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

Model Number TRIA

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device udi not provided as this product is no longer manufactured.No parts were replaced.No parts have been received by manufacturer for evaluation.

Event Description

A medtronic representative reported that during a cranial resection procedure the monitor of navigation system displayed a black screen.Another monitor with external output was used to complete the procedure.The procedure was completed with the use of navigation.There was no delay to the procedure due to the reported issue.No impact on patient outcome.

Manufacturer Narrative

Correction: a medtronic representative reported that they went to the site to test the navigation system.The representative reported that they could replicate the reported issue.Part replacement could not be performed on the navigation system as the system is no longer manufactured.

• Brand Name: STEALTHSTATION TRIA
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6838036
• MDR Text Key: 84354061
• Report Number: 1723170-2017-03580
• 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,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TRIA
• Device Catalogue Number: 9731382
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1