MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for ELECTROCONVULSIVE THERAPY MACHINE manufactured by Mecta Corporation.
[128265665]
Since approx more than 80 maintenance bilateral ect, in addition to pervasive autobiographical memory loss, working memory deficits and impaired cognitive processing speed, i now have a new development. Any time i get my bacterial, viral or fungal infection, it goes directly to my brain triggering painful dystonia. Airborne pathogens go directly to my brain at times triggering painful dystonia, dyskinesia-type erratic movements, parkinsonism-type gait and most recently diaphragmatic paralysis. I believe this is a direct result of ect's hypertensive surge bursting lesions causing blood-brain-barrier hyper permeability. Cognitive and neuromuscular function is directly related to whatever pathogens are in the air and/or blood borne biotoxins (including digestive byproducts). I was hospitalized overnight in the fall of 2017. I've had multiple visits to the er. The problem has progressed to the point that i experience diaphragmatic paralysis 3-10 or more times a month (if i choose to go into buildings which aren't hepa filtered). Instead, i am basically confined to my home and hepa air-filtration, forced to quit working due to the inconsistency of my neurological, neuromuscular and respiratory problems. Dystonia, and respiratory problems completely ameliorate when i am pathogen-free. The date listed is merely the most recent incident. Uncertain which model.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081540 |
| MDR Report Key | 8095060 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-11-17 |
| Date Added to Maude | 2018-11-21 |
| 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 | 0 |
| Brand Name | ELECTROCONVULSIVE THERAPY MACHINE |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2018-11-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Brand Name | ELECTROCONVULSIVE THERAPY MACHINE |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2018-11-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION / SOMATICS LLC |
| Brand Name | ELECTROCONVULSIVE THERAPY MACHINE |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2018-11-20 |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 10 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2018-11-20 |