MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for MECTA SPECTRUM manufactured by Mecta Corporation.
[185222057]
I have amnesic disorder and following the ect my memory was severely affected. I already had severe memory loss and after ect i couldn't remember names of distant family, friends. My memory was i feel like almost erased. I could not remember hardly anything. I had extreme problems trying to concentrate. I also started suffering with severe migraine headaches. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093931 |
| MDR Report Key | 9883050 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-24 |
| Date of Event | 2015-06-24 |
| Date Added to Maude | 2020-03-26 |
| 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 | MECTA SPECTRUM |
| Generic Name | DEVICE, ELECTROCONSULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |