FDA Adverse Event
Death
Summary report: N
NIOBE MAGNETIC NAVIGATION SYSTEM
MDR report key: 775650
·
Received October 31, 2006
Report
- Report Number
- 3003084417-2006-00002
- Event Type
- Death
- Date Received
- October 31, 2006
- Date of Event
- October 2, 2006
- Report Date
- October 31, 2006
- Manufacturer
- STEREOTAXIS, INC.
- Product Code
- MQB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.3., H.6.: THE NIOBE SYSTEM IS NOT AN INVASIVE PRODUCT AND PERFORMED AS INTENDED. THE ADVERSE EVENT THAT OCCURRED MAY HAVE BEEN CAUSED BY ANOTHER PRODUCT USED DURING THE PROCEDURE.
Description of Event or Problem · 1
PROCEDURE BEGAN WITH NAVISTAR RMT. THE PROCEDURE WAS UNSUCCESSFUL USING THIS MAGNETIC CATHETER. NO WAS NOTED. DR WENT TO A CONVENTIONAL BIOSENSE WEBSTER 8MM CATHETER TO ABLATE. THE PROCEDURE WAS SUCCESSFUL THIRTY MINUTES AFTER THE PROCEDURE, DR WAS CALLED BACK TO THE ROOM. THE PATIENT WAS NONRESPONSIVE. FIVE MINUTES AFTER THE RETURN OF THE PHYSICIAN, CODE BLUE WAS CALLED. PATIENT SUBSEQUENTLY EXPIRED IN THE ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NIOBE MAGNETIC NAVIGATION SYSTEM | STEERABLE CATHETER CONTROL SYSTEM | MQB | STEREOTAXIS, INC. | 001-003000-2 | 0019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| L| R | BIOSENSE WEBSTER, INC NAVISTAR RMT 4MM CATHETER |