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

Model Number BI70000027120

Device Problem Wireless Communication Problem (3283)

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

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to canadian patient privacy regulations.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a procedure, the trackers on the imaging system could not be viewed by two separate medtronic navigation systems.It was reported that after a reboot of the imaging system, the trackers could be viewed.After an image acquisition, a medtronic navigation system was transported out of the operating room (or) where it could view one side of trackers on the imaging system and not the other.A subsequent reboot of the imaging system restored functionality.There was no reported impact on patient outcome.(b)(6)2020 rep: additional information was received stating that the procedure being performed was a sacroiliac and thoracolumbar procedure.There was about a 10-15 minute delay in the case.There was no impact on 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 (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10179291
• MDR Text Key: 196222091
• Report Number: 3004785967-2020-00719
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2020

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: BI70000027120
• Device Catalogue Number: BI70000027120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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