MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for THYMATRON BY SOMATICS manufactured by Somatics, Llc.
[139413959]
Patient identified the hospital where ect treatments were received. A review of our files showed that the hospital purchased a mecta model d prior to 1988 which they stopped using prior to 4/18/1990. The hospital switched to a somatics thymatron device at that time, which we verified they have continued to use through 2014 and likely to the present day. The patient's last ect treatment was in 2009. Thus, at least the last 19 years of the patient's treatments were not done with a mecta device.
Patient Sequence No: 1, Text Type: N, H10
[139413960]
Various medical problems claimed to be consequence of more than 80 maintenance bilateral ect treatments, including: memory loss, cognitive impairments, neurological problems following infections. Patient says "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 hyperpermeability. ... " "the data listed is merely the most recent incident. " summarizing: the patient completed ect in 2009. She is now experiencing neurological problems following infections. She believes this to be a result of her ect therapy. See medwatch report mw5081540 for full details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3020533-2019-00001 |
| MDR Report Key | 8437679 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2018-11-17 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ROBIN NICOL |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal | 97062 |
| Manufacturer Phone | 5036126780 |
| Manufacturer G1 | MECTA CORPORATION |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THYMATRON BY SOMATICS |
| Generic Name | ECT DEVICE |
| Product Code | GXC |
| Date Received | 2019-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | 720 COMMERCE DRIVE, UNIT 101 VENCIE FL 34292 US 34292 |
| Brand Name | THYMATRON BY SOMATICS |
| Generic Name | ECT DEVICE |
| Product Code | GXC |
| Date Received | 2019-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | 720 COMMERCE DRIVE, UNIT 101 VENCIE FL 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |