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 Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.It was not possible to reproduce the issue.No parts were replaced or returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in a spinal fusion procedure the site had an error display on the imaging system during a post op spin indicating that the 3d spin was not completed.The representative reported that everything appeared normal with regards to work flow of taking a spin, however the error came up as well as a dose report for the patient during the pre-operative spin.There was no delay to the procedure or impact on the patient outcome.

Manufacturer Narrative

The event reported in this 3500a also represents a potential accidental radiation occurrence (aro) per 21 cfr 1002.20(a).Per 21 cfr 1002.20(c), this event is being reported under part 803.Supplemental aro information is as follows: nature and circumstances of aro.Location of aro: (b)(6).Number of persons exposed: 1.Number of persons adversely affected: 0.Actions taken to control, correct, or eliminate: see narrative above and/or previous mdr submissions.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7046864
• MDR Text Key: 93179444
• Report Number: 1723170-2017-04776
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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: 62 YR
• Patient Weight: 78