FDA Adverse Event
Malfunction
Summary report: N
STEREOTAXIS SYSTEM
MDR report key: 23498049
·
Received November 7, 2025
Report
- Report Number
- MW5178641
- Event Type
- Malfunction
- Date Received
- November 7, 2025
- Date of Event
- October 29, 2025
- Report Date
- November 4, 2025
- Manufacturer
- OMEGA MEDICAL IMAGING INC. / STEREOTAXIS, INC.
- Product Code
- PJB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PVC ABLATION WHEN BOTH THE STEREOTAXIS SYSTEM AND FLUOROSCOPY FAILED, RESULTING IN THE PROCEDURE BEING ABORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187120 | STEREOTAXIS SYSTEM | CATHETER REMOTE CONTROL SYSTEM | PJB | OMEGA MEDICAL IMAGING INC. / STEREOTAXIS, INC. | CS20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |