MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for SOMATICS THYMATRON SYSTEM IV EDIV manufactured by Somatics Llc.
[185481096]
Trying to get with symptoms of cervical and lumbar radiculopathy and dystonia since very young. Was misdiagnosed with schizophrenic by psychiatrist. I got psychiatrists. I got serotonin syndrome from drugs that were prescribed. The psychiatrist told me i have no other treatment left beside e. C. T. And was giving 22 e. C. T. Treatments in 45 days. Treatment are extremely painful to the head and neck. Extreme headaches and pain through head. Short term memory loss after 2 treatments. Extreme mental confusion and loss of memory. Experience nausea and vomiting. Symptoms continually getting with every treatment. As treatments continue memory and functionally become almost impossible. The thought process is very completely broken. Relearning how to think is what's next. Relearn how to drive. Feels like you got hit in head with sledge hammer. A lot of brain damage is very possible. Extreme pain in head and neck. Hands and legs went numb. Couldn't move head left or right. Had a lot of physical therapy to regain motion in neck. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093944 |
| MDR Report Key | 9888406 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2016-09-01 |
| Date Added to Maude | 2020-03-27 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATICS THYMATRON |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2020-03-26 |
| Model Number | SYSTEM IV |
| Catalog Number | EDIV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2020-03-26 |