MAUDE Adverse Event Report: NEUROMERCHANICAL INNOVATIONS, LLC IMPUSE IQ

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Paralysis (1997)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Living in (b)(6), i would experience muscle ache from the cold and therefore went to chiropractor dr (b)(6) for an adjustment because my primary chiropractor was not available that day.He used an instrument on me called an impulse iq.After getting home, i did not feel well.I went to sleep thinking that i was sore from the adjustment, but would go on to suffer extreme pain for 4 yrs.This ache did not feel the same as the muscle ache that i had been experiencing from the cold.I had pain in a spot on my spine which radiated to my right scapula.I felt like someone had stabbed me and could feel blood dripping from my inside.I would have pain even in my sleep.This led me to walking in and out of dr's offices for 4 yrs to find a cure for the pain.I was admitted to the emergency room at least 5-6 times at the most acute moments of this pain.I came to find out that my pain was from having a pinched nerve.I'm 100% certain and without a doubt believe that my pinched nerved was caused the day i went to dr (b)(6)'s office.I believe that it was caused by this instrument.The last time i was hospitalized for this pain was on the (b)(6) 2017.The x-ray revealed that i have scoliosis.I believe that because my vertebrae are not straight, it made it easy for my spine to become destabilized and allow my nerve to become trapped in between my vertebrae.I'm awaiting x-rays and scars from hospitalizations prior to my encountered with dr (b)(6) for comparison with my current ones, because i had never been told that i had scoliosis before.There are no words to describe the amount of pain and torture i went through these 4 yrs.I started developing paralysis in my right arm, experienced trouble breathing, among many other symptoms that developed after this injury.

• Brand Name: IMPUSE IQ
• Type of Device: IMPUSE IQ
• Manufacturer (Section D): NEUROMERCHANICAL INNOVATIONS, LLC
• MDR Report Key: 7237845
• MDR Text Key: 99076474
• Report Number: MW5075027
• Device Sequence Number: 1
• Product Code: LXM
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Weight: 53