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 Computer Software Problem (1112); Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

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.The representative scanned right and left sides of the spine model with 2 separate navigation's system without issue.It was not possible to duplicate the reported 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 imaging system was showing an alleged inaccuracy of approximately 4mm after taking a spin.The site then brought in another imaging system, took a second spin, and confirmed accuracy.There was a reported delay to the procedure of less than 1 hour due to this issue and no 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.(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 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. (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: 7224697
• MDR Text Key: 98539605
• Report Number: 1723170-2018-00432
• 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: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physicist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2013
• 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 Age: 67 YR
• Patient Weight: 113