MAUDE Adverse Event Report: ALAN NEUROMEDICAL TECHNOLOGIES VECTTOR, VT - 200; INTERFERENTIAL CURRENT THERAPY

Model Number VECTTOR DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); High Blood Pressure/ Hypertension (1908); Pain (1994); Shock (2072); Alteration In Body Temperature (2682)

Event Date 02/13/2019

Event Type  Injury  

Event Description

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.

• Brand Name: VECTTOR, VT - 200
• Type of Device: INTERFERENTIAL CURRENT THERAPY
• Manufacturer (Section D): ALAN NEUROMEDICAL TECHNOLOGIES
• MDR Report Key: 8436245
• MDR Text Key: 139367297
• Report Number: MW5085010
• Device Sequence Number: 1
• Product Code: LIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VECTTOR DEVICE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACDF C4-C6 ; BACK AND NECK BRACE AS NEEDED; ESSENTIAL OILS ; HEATING PADS; LAMINECTOMY C4-C7 ; MULTIVITAMIN WITHOUT POTASSIUM; PILATES MACHINE; THYROXINE 75MG; TRIPHALA GUGGULU
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 59