MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-19 for NEUROSTAR TMS manufactured by Neuronetics Inc..
[70791676]
I started a tms transcraneal magnetic stimulation treatment as part of a residence program at (b)(6). The medical device was branded neurostar - model number unk. After 5 or 6 treatments i asked the attending psychiatrist to stop the treatment because i noticed problems with long term memory recall and speech. Ten months later the memory recall problem have persisted. I never had these problems before and they started during tms treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068607 |
| MDR Report Key | 6427595 |
| Date Received | 2017-03-19 |
| Date of Report | 2017-03-19 |
| Date of Event | 2016-05-27 |
| Date Added to Maude | 2017-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 TMS |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2017-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS INC. |
| Brand Name | NEUROSTAR TMS |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OKP |
| Date Received | 2017-03-19 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2017-03-19 |