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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A medtronic representative received a report that while in a spine procedure, a site was having issues with the imaging system image quality.No further details regarding this concern were provided.The surgeon opted to discontinue the use of the navigation system and the imaging system after anesthesia and skin incision.The surgeon completed the procedure after a one hour delay.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier not made available from the site.In trouble-shooting, a medtronic representative reviewed images and determined their kv values for 3d scans were too low, the scans were set to 40kv.Patient anatomy was also noted to be a factor in the reported issue.A medtronic representative, following-up at the site, reported making recommendations to the site to take images with 120kv.Per the medtronic representative, all phantoms passed tests: 3d, contrast and resolution.No parts have been returned to manufacturer for analysis.

• 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: 4470969
• MDR Text Key: 15475991
• Report Number: 1723170-2015-00112
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• 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: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Weight: 64