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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 01/15/2014

Event Type  Injury  

Event Description

A site representative, neuro coordinator, reported that while in a spine procedure, and 80 percent of the way through a spin with the o-arm, the imaging system shut down unexpectedly.It was stated that a critical battery level error message was displayed on the system pendant.The site attempted to charge the system during the procedure to enable them to take another spin, however, the o-arm shut off.The surgeon opted to discontinue the surgery.The procedure would be rescheduled.

Manufacturer Narrative

Device manufacturing date is unavailable.A medtronic representative, following-up at the site, reported the surgery was halted after there was an incision.The surgeon discontinued the use of the navigation and the imaging system and the patient would need to be rescheduled.Replacement motor battery charger shipped to site.Returned suspect device found to be defective.Replacement battery conn cable shipped to site.Suspect device not returned to manufacturer for analysis.Replacement battery shipped to site.Suspect battery not returned to manufacturer for analysis.Replacement motion control pcb shipped to site.Suspect device found to be defective.2 replacement relays shipped to site.Returned replacement devices unused.Original found to be good, replacements not needed.2 replacement pfc boards shipped to site.Two returned; one for troubleshooting the other unknown defect.Replacement motor battery charger shipped to site.Good - not needed - used pcb for troubleshooting purposes.Multiple boards and components were changed to diagnose the power issue.After replacing suspect components with new components the system was tested whereby it passed all system tests.(b)(4) 2014 medtronic representative performed an imaging system check-out.All areas passed.Defective components: pcba bi30000163r pwr sw brd assy rwk; pcba bi31000158 motion control pcb; pcba bi31000172 pfc board 1000.

Manufacturer Narrative

Correction: considered an adverse event and serious injury as an incision was made when the surgeon cancelled the case and rescheduled it for the following monday ((b)(6) 2014).According to the site, the rescheduled case went well.O-arm imaging and navigation were used, both systems functioned properly.

• 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 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 3625390
• MDR Text Key: 4205346
• Report Number: 1723170-2014-00126
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2007
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 108