MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for VECTTOR, VT - 200 VECTTOR DEVICE manufactured by Alan Neuromedical Technologies.
[139367297]
I was during a trial of the ic/ems / tens unit which caused severe multisystem dysautonomia. The system was hooked up to my feet and hands and arms, and it first sent a feeling of pressure as the current stimulates the cells to release endogenous opioids. Then when these wore off my body went into shock, where my body temperature was not able to self regulate. I experienced severe neuralgia in my head, high blood pressure and severe sympathetic overload. The test was for 2 days and it initially provided a sense of relief and no pain. I live with constant pain from spinal cord injury. The device immediately took the pain away by stimulating release of enkephalins and pomc derivatives, it made me feel very drunk, but as the effect wore off, the sympathetic dysfunction began which tested for more than 6 weeks of severe pain and dysfunction of autonomic system, left side of heart out of synch with right, unable to digest food, severe pain, edema in legs, required intervention and steroids and hospital care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085010 |
| MDR Report Key | 8436245 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-16 |
| Date of Event | 2019-02-13 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | VECTTOR, VT - 200 |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2019-03-19 |
| Model Number | VECTTOR DEVICE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALAN NEUROMEDICAL TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2019-03-19 |