MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Human-Device Interface Problem (2949)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.The representative did a test spin and had no issues.The 3d spin did not have a [nav] tag on the system.The logs show that the radiologic technologist (rt) unchecked and navigated spin box and then confirmed and then took a spin right after.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the site was having issues transferring images.The navigation system was stating that the transfer exam doesn't have registration information and a manual registration is required.The representative tried pushing the scans manually but still received the error.Both systems were rebooted and the navigation system was swapped out for another on-site.The representative was able to re establish connection with the new navigation system and the imaging system take another spin and the system was able to transfer the exam over with out an error.It is unknown if there were any delay to the procedure, but there were no impact on patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

There was a less than 1-hour delay to the procedure.

• Brand Name: NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8621403
• MDR Text Key: 145423803
• Report Number: 1723170-2019-02414
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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 Age: 12 YR
• Patient Weight: 90