MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-04 for NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION 3.2 001-006100-1 manufactured by Stereotaxis, Inc.
| Report Number | 3003084417-2018-00002 |
| MDR Report Key | 8961120 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-04 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-04 |
| Device Manufacturer Date | 2008-04-28 |
| Date Added to Maude | 2019-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR ABDUL GHANDI |
| Manufacturer Street | 4320 FOREST PARK AVE SUITE 100 |
| Manufacturer City | ST LOUIS MO 63108 |
| Manufacturer Country | US |
| Manufacturer Postal | 63108 |
| Manufacturer Phone | 3148057875 |
| Manufacturer G1 | STEREOTAXIS, INC |
| Manufacturer Street | 4320 FOREST PARK AVE SUITE 100 |
| Manufacturer City | ST LOUIS MO 63108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION |
| Generic Name | NIOBE |
| Product Code | NDQ |
| Date Received | 2019-09-04 |
| Model Number | 3.2 |
| Catalog Number | 001-006100-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STEREOTAXIS, INC |
| Manufacturer Address | 4320 FOREST PARK AVE SUITE 100 ST LOUIS MO 63108 US 63108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-04 |