IMPUSE IQ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-01 for IMPUSE IQ manufactured by Neuromerchanical Innovations, Llc.

Event Text Entries

[99076474] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075027
MDR Report Key7237845
Date Received2018-02-01
Date of Report2018-01-31
Date of Event2014-02-26
Date Added to Maude2018-02-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIMPUSE IQ
Generic NameIMPUSE IQ
Product CodeLXM
Date Received2018-02-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEUROMERCHANICAL INNOVATIONS, LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2018-02-01

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