MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9732719

Device Problem Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial procedure.It was reported that the camera was unable to see the imaging systems trackers.The site tried to cover and expose the leds and sensor to restart the leds.They moved the camera but that did not resolved the issue.There were no close or lights.The site rebooted the gantry and to move the navigation system to the other side, but the issue was not resolved.The site aborted the use of the imaging and navigation system.The mayfield position would not allow for correct patient position in the gantry so they were unable to get a good registration spin.There was a reported delay of less than one hour and no reported impact to patient outcome.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9558140
• MDR Text Key: 184508081
• Report Number: 1723170-2020-00062
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2020

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: Health Professional
• Device Model Number: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/07/2020
• 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: 69 YR
• Patient Weight: 86