NIOBE MNS SIEMENS
Report
- Report Number
- 3003084417-2021-00401
- Event Type
- Injury
- Date Received
- February 28, 2022
- Date of Event
- December 10, 2021
- Report Date
- December 20, 2021
- Manufacturer
- STEREOTAXIS
- Product Code
- NDQ
- PMA / PMN Number
- K192775
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685795 | NIOBE MNS SIEMENS | NIOBE ES SIEMENS | NDQ | STEREOTAXIS | ES SIEMENS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Other |