MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Image Resolution Poor (1306); Poor Quality Image (1408); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2014

Event Type  malfunction  

Event Description

A radiology technician (rt) reported that while in a spinal fusion procedure, the 2d images from imaging system appeared as horizontal blocks on the navigation system.While troubleshooting the issue, the site attempted to reboot the imaging system but it did not resolve the issue.After a 45 minute delay and prior to patient incision, the surgeon opted to cancel the procedure and re-schedule it for a later date.The rescheduled surgery was successful with no reported issues.

Manufacturer Narrative

Patient identifier not available from the site.Patient weight not available from the site.Initial reporter last name was not provided.A medtronic representative, following up with the site, confirmed that a step wedge image shows up when 2d fluoro is taken.The medtronic representative tested the system and determined the detector panel was defective.Replacement device shipped to site for issue resolution.The medtronic representative replaced the detector panel, configured the paxscan to the detector, and performed an imaging system check-out, all areas passed.Medtronic investigation of the returned suspect device confirmed the detector panel was defective.The paxscan was not applying corrections to image properly.Detector displayed a stop wedge image when 2d fluoros was taken.2d images had many pixelated vertical lines.Issue could not be corrected with calibration.The reported event was confirmed to be caused by an electrical failure mode of the paxscan component within the detector panel.A navigation system software investigation was completed.The image coming from the imaging system had the artifacts, meaning the problem originated in the imaging system.The navigation system spine software is functioning as designed.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4237639
• MDR Text Key: 17161995
• Report Number: 1723170-2014-01197
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 10/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2007
• 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
• Treatment: STEALTHSTATION S7 SYSTEM
• Patient Age: 20 YR