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

Catalog Number BI70002000

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by manufacturer for evaluation.

Event Description

A medtronic representative reported that during a mid-level lumbar spinal fusion procedure, the imaging system became unresponsive while setting up for a case.The procedure was completed with the use of imaging.There was a delay of 2 hours.No impact on patient outcome.

Manufacturer Narrative

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

Event Description

Medtronic received information regarding an imaging device during a sacroiliac and thoracolumbar procedure.It was reported intraoperatively that device was freezing during set up.Surgical delay was reported as two hours.No known impact on patient outcome.

Manufacturer Narrative

The manufacturer representative went to the site the test the imaging system.The reported issue was confirmed and despite several attempts, they were unable to repair the device.They made an exchange with a new imaging system.They repaired the damaged system once it was removed from the site and they were able to repair all issues with the system and now it is being used for demo equipment.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device during a sacroiliac and thoracolumbar procedure.It was reported intraoperatively that device was freezing during set up.Surgical delay was reported as two hours.No impact on patient outcome.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7029146
• MDR Text Key: 92862504
• Report Number: 1723170-2017-04648
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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: 53 YR
• Patient Weight: 77