MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-22 for SOMATICS AND MECTA CORPORATION SYSTEM IV EDIV manufactured by Somatics, Llc.
[139607000]
Somatics became aware of the claimed adverse events upon receipt of a lawsuit filing. This was a general class action lawsuit that started with six individuals, but over the years was down to only two people. The exact dates of any treatments and any doctors was not provided to somatics. In general several hospitals were selected that had thymatron system iv devices. The judge threw out most of the complainants and most of the types of injuries. Somatics received no specific information about the treating physician, dates of treatments, laboratory results or other objective information to corroborate the complainants' description of these events. Moreover the medical literature provides no evidence of the connection drawn by the complainants between ect treatments and the symptoms reported. Somatics maintains that the thymatron device did not cause or contribute to these injuries. In the 12/26/2018 ruling, the fda itself declared that there is no documented proof that ect causes any brain damage or these types of alleged injuries. These events were reported to the company through legal channels which limited the company's ability to conduct a full investigation, accordingly, out of abundance of caution and to ensure full compliance with 21 cfr part 803, somatics is reporting these events based on the allegations that were made rather than because it reached any conclusion that the device caused or contributed to these injuries.
Patient Sequence No: 1, Text Type: N, H10
[139607001]
(b)(6) and several complainants claimed multiple adverse affects including permanent brain injury, severe cognitive and memory impairment and organic brain syndrome. This was part of the litigation for a class action suit against both somatics and mecta corporation, or in general against ect practice. Most members of the litigation were eliminated because they could not provide documentation of their treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2019-00002 |
| MDR Report Key | 8445240 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-21 |
| Date Mfgr Received | 2017-01-08 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID MIRKOVICH |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal | 34292 |
| Manufacturer Phone | 8006426761 |
| Manufacturer G1 | SOMATICS, LLC |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34292 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATICS AND MECTA CORPORATION |
| Generic Name | THYMATRON SYSTEM IV AND MECTA SPRECTRUM 5000 |
| Product Code | GXC |
| Date Received | 2019-03-22 |
| Model Number | SYSTEM IV |
| Catalog Number | EDIV |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | SUITE 101 720 COMMERCE DRIVE VENICE FL 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-22 |