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

Model Number TRIA

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Injury (2348); Iatrogenic Source (2498)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Device udi not provided as this product is no longer manufactured.A medtronic representative went to the site to test the equipment.The representative reported that the uninterruptible power supply (ups) for the navigation system was faulty.

Event Description

A medtronic representative reported that, while in a spinal fusion, the navigation system was not powered on.The navigation system was restarted and immediately powered down.The procedure was then cancelled and postponed for another day.No additional information was provided.

Manufacturer Narrative

Correction: device serial number now provided as it was inadvertently left off initial mdr.Correction: the procedure was canceled and then rescheduled after an incision had already been made.New fda patient coded added.Additional investigation was performed.Review of the system history determined this navigation system is 13 years old and has no indication of prior ups replacements.Investigation is unable to determine probable cause as no part was not returned and system checkout was not fully completed after multiple attempts.

• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6648771
• MDR Text Key: 77820468
• Report Number: 1723170-2017-02543
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2004
• 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
• Patient Outcome(s): Required Intervention