MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000-G27

Device Problem Image Reversal (1358)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding an imaging device being used for a spinal fusion procedure.It was reported that after the image was taken, the orientation was incorrect.The left was right and right was left.Another imaging system was used and they were able to orient the images on it.The initial navigation system displayed the incorrect orientation based on the radiographic images taken.The sites confirmation image was oriented correctly.There was no reported impact on patient outcome.There was no reported delay to the procedure due to this issue.

Manufacturer Narrative

Additional information: udi number provided.

Event Description

There was a reported delay of 5 minutes to the procedure due to this issue.

Manufacturer Narrative

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

Event Description

The issue was the x-ray tech selected the wrong patient orientation.This appeared on the imaging guided surgical system and navigation system as it was on the imaging system.On the imaging guided surgical system, the manufacturer representative re-oriented the patient to the correct orientation.No system checkout needed as the system was functioning as intended.Re-orienting the image restored functionality.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7508914
• MDR Text Key: 108154804
• Report Number: 1723170-2018-02008
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G27
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 45