MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for NEUROSTAR manufactured by Neuronetics, Inc..
[77634156]
Caller would like to raise awareness that there may be more side effects than advertised. He started treatment (b)(6), and continued five times a week, for 2 weeks. Side effects included, short-term memory loss, fear, panic, confusion, auditory hallucinations, intensified migraines, anxiety, worsened depression, agitation, and anger. Caller has discontinued use of product and returned to previous psychiatrist. Medication adjustments were made to counteract side effects and verbal therapy sessions were increased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070381 |
| MDR Report Key | 6639538 |
| Date Received | 2017-06-13 |
| Date Added to Maude | 2017-06-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEUROSTAR |
| Generic Name | TMS |
| Product Code | OBP |
| Date Received | 2017-06-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |