MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-12-10 for NEUROSTAR TMS SYSTEM NEUROSTAR TMS 1.0 81-60000-000 manufactured by Neuronetics Inc..
[19285208]
Pt suffering from major depression became hospitalized, due to suicidal ideation.
Patient Sequence No: 1, Text Type: D, B5
[19515949]
Neuronetics received medwatch report, (b) (4), from fda on november 13, 2009). Initial reporter did not notify neuronetics of event. Identification or contact info of pt, initial reporter, and prescribing physician was not provided, therefore, neuronetics could not follow-up to obtain additional info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2009-00001 |
| MDR Report Key | 1589995 |
| Report Source | 00 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-12-08 |
| Date of Event | 2009-10-02 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2010-02-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY WAYS, PH.D., VP |
| Manufacturer Street | 31 GENERAL WARREN BOULEVARD |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6109814107 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION SYSTEM |
| Product Code | OBP |
| Date Received | 2009-12-10 |
| Model Number | NEUROSTAR TMS 1.0 |
| Catalog Number | 81-60000-000 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS INC. |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2009-12-10 |