MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-14 for NEUROSTAR manufactured by .
[1950817]
An (b)(6) woman with history of treatment-refractory major depression receiving rtms using neurostar device for "off-label" indication (refractory to >1 antidepressant). She developed syndromic mania with suicidal preoccupation on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020313 |
| MDR Report Key | 2065728 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-04-13 |
| Date Added to Maude | 2011-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR |
| Generic Name | NONE |
| Product Code | OBP |
| Date Received | 2011-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-04-14 |