MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-04 for NEUROSTAR TMS manufactured by Neuro Star.
[2620498]
Transcranial magnetic stimulation by neurostar used (b)(6) 2010, 5 times/week for 6 weeks, 1 hour per session. (b)(6) noted to have clear manic episode, first in pt's history. No new medications during that time. No life changes. Dates of use: (b)(6) 2010. Reason for use: treatment resistant depression.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024977 |
| MDR Report Key | 2532422 |
| Date Received | 2012-04-04 |
| Date of Report | 2002-04-04 |
| Date of Event | 2011-04-07 |
| Date Added to Maude | 2012-04-13 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 TMS |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION |
| Product Code | OBP |
| Date Received | 2012-04-04 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURO STAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-04 |