NIOBE MNS SIEMENS
Received Feb 28, 2022 · Event occurred Dec 10, 2021
Report 3003084417-2021-00401 · MDR key 13619859
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
49 YR · Male
- Heart Block
- Heart Block
Narrative
Description of Event or Problem
THE PHYSICIAN HAD COMPLETED MAPPING AND MOST OF THE ABLATION, A FINAL ABLATION WAS PERFORMED CLOSE THE CORONARY SINUS OSTIUM AND THEN HEART BLOCK HAPPENED. THE PHYSICIAN WAITED ABOUT AN HOUR FOR CONDUCTION TO COME BACK, IT CAME BACK ABOUT 2:1, PLANNING TO MONITOR THE PATIENT FOR A FEW DAYS BEFORE DECIDING IF A PACEMAKER IS REQUIRED. THE NIOBE SYSTEM AND NAVIGANT SOFTWARE WERE USED ACCORDING TO THEIR LABELED INDICATIONS. THE PATIENT ANATOMY WAS THOUGHT BY THE PHYSICIAN TO HAVE CONTRIBUTED TO THE EVENT, WITH A POSSIBILITY OF THE AV NODE RUNNING THROUGH THE AREA OF ABLATION.
Description of Event or Problem
THE PHYSICIAN HAD COMPLETED MAPPING AND MOST OF THE ABLATION, A FINAL ABLATION WAS PERFORMED CLOSE THE CORONARY SINUS OSTIUM AND THEN HEART BLOCK HAPPENED. THE PHYSICIAN WAITED ABOUT AN HOUR FOR CONDUCTION TO COME BACK, IT CAME BACK ABOUT 2:1, PLANNING TO MONITOR THE PATIENT FOR A FEW DAYS BEFORE DECIDING IF A PACEMAKER IS REQUIRED. THE NIOBE SYSTEM AND NAVIGANT SOFTWARE WERE USED ACCORDING TO THEIR LABELED INDICATIONS. THE PATIENT ANATOMY WAS THOUGHT BY THE PHYSICIAN TO HAVE CONTRIBUTED TO THE EVENT, WITH A POSSIBILITY OF THE AV NODE RUNNING THROUGH THE AREA OF ABLATION.