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 Display Error/Artifact (1304); Image Resolution Poor (1306); Device Operates Differently Than Expected (2913)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 01/26/2015

Event Type  Injury  

Event Description

A site radiographic technologist (rt) reported that, while in a spine fusion procedure the previous night, the surgeon attempted to use their imaging system to take a confirmation spin.When taking localizer shots, the imaging system made a sharp chirp sound instead of the normal beep and the image that was displayed on the mobile viewing system (mvs) was purely gray static.The surgeon opted to discontinue the use of the imaging system for the confirmation spin and brought in a c-arm to continue.The surgeon completed the procedure with the use of the navigation system.

Manufacturer Narrative

Patient weight not made available from the site.Return requested.Replacement atp console shipped to site 01/27/2015.Suspect atp console returned to manufacturer on 02/10/2015; under analysis.Return requested.Replacement atp u24 eprom shipped to site 01/27/2015.Suspect atp u24 eprom has not been returned to manufacturer for analysis.On 01/28/2015 a medtronic representative performed an imaging system check-out, all areas passed.Found that ribbon cable between atp console and flouro cpu was not fully seated.Re-connected and re-configured generator.System performed as intended.Return requested.Replacement fluoro u9 eprom shipped to site 01/29/2015.Suspect fluoro u9 eprom has not been returned to manufacturer for analysis.Return requested.Replacement ht controller pcb shipped to site 01/29/2015.Suspect ht controller pcb has not been returned to manufacturer for analysis.Return requested.Replacement ht u5 eprom shipped to site 01/29/2015.Suspect ht u5 eprom has not been returned to manufacturer for analysis.Return requested.Replacement system control board assy shipped to site 01/29/2015.Suspect system control board assy has not been returned to manufacturer for analysis.On 01/30/2015 a medtronic representative performed an imaging system check-out, all areas passed.Identified an x-ray state error.Replaced the atp console and re-loaded software.System performed as intended.On 01/30/2015 a medtronic representative, following-up at the site, reported that the patient went for a post-op computed tomography (ct) to confirm screw placement and it was determined that t10 left side, a screw was a few millimeters from the aorta, there was no puncture.Under 2d fluoro in the room, the site reported it looked normal.Revision surgery was performed to place the screw on t10 in a better location.(b)(6) 2015 it was reported that the surgeon used navigation for all the screws.When the surgeon was fixating the rod, the surgeon advanced the screw a couple of full turns to adjust the height of the screw head to align the rod with the other screws.The surgeon advanced the screw without navigation.

Manufacturer Narrative

The software investigation confirmed onsite testing (previously reported on the initial 3500a) that the reported event was unrelated to a software issue.The logs showed an x-ray state error that pointed to an issue with the atp console board.The software functioned as designed.The atp console board was returned to the manufacturer for analysis and was found to have an electrical issue.The board was installed on a test system.Initially the system powered up ok, but as the atp console board warmed up a chirp sound came from the generator near the board and a snowy output image appeared on the mobile view station (mvs).The reported event was confirmed.The device was replaced to resolve the issue.All other components listed on the initial 3500a were returned unused.

Manufacturer Narrative

As previously reported testing confirmed the reported event was due to the atp console board.The part was sent to the supplier for investigation and supplier testing found the failure was due to ¿a 50 ohm leakage impedance [oscillating] in pin 7 of j13 that makes the system to select digital modus (dsi) without user selection.¿.

• 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.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4547508
• MDR Text Key: 5520476
• Report Number: 1723170-2015-00237
• 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: Other,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• 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
• Patient Age: 70 YR