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

Model Number BI-700-00028-120

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 12/17/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that while in a spinal fusion procedure, the site was unable to obtain usable images from the imaging system.The images were appearing either grainy or half the image very light and the other half very dark.Attempting to obtain usable images caused over an hour delay to the procedure.After an incision was made, the surgeon opted the procedure without the use of the imaging system or navigation system.There was no known impact on patient outcome.

Manufacturer Narrative

Patient identifier not available from the site.A medtronic representative, following up with the site, reviewed the images and noticed that the kv value was at 40.The medtronic representative suggested that the site test the image with higher kv and ma values.A software investigation is on-going.

Manufacturer Narrative

A medtronic representative reported that the issue was resolved by replacing the o-arm pendant.The pendant was set to the lowest kilovolts (kv) setting.The software investigation found that the reported event was unrelated to a software issue.The image quality issues resulted from the lowest settings for kilovolts (kv) on the pendant.

Manufacturer Narrative

Further software analysis found that the reported event was unrelated to a software issue.The software logs from the reported incident were examined to investigate the matter.Regarding the alleged light/dark image issue, the logs did not show any warnings or errors suggesting an issue with the software.Regarding the 3d image, the logs indicated a 3d scan started at 6:59:54 and was acquired without incident.The logs indicated reconstruction successfully completed.There were no warnings or errors that would suggest an issue with image reconstruction.At 7:01:11, the logs showed the 3d reconstruction was saved to disk.The logs also showed the 3d scan was taken at 40 kv after the user repeatedly pressed the pendant.The technician at the site also noticed a kv value of 40 in a grainy 2d image.A low kv value may result in image quality issues.The software functioned 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.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4424524
• MDR Text Key: 5418931
• Report Number: 1723170-2015-00070
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2014
• 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: 61 YR
• Patient Weight: 93