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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION MACHINE; TRANSCRANIAL MAGNETIC STIMULATOR

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NEURONETICS, INC. NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION MACHINE; TRANSCRANIAL MAGNETIC STIMULATOR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Anxiety (2328); Depression (2361); Palpitations (2467); Cognitive Changes (2551)
Event Date 08/13/2019
Event Type  Injury  
Event Description
I received 36 tms treatments on the neurostar machine.After about 5 treatments, my anxiety got very high.I would have racing thoughts and my heart felt like it was going to beat out of my chest.I had problems sleeping as well.The dr and tech didn't seem too concerned.This continued for a couple weeks and i crashed into a worse depression i've ever had.I began having suicidal thoughts.While i thought it was normal, as i heard from several people - it has never let up.It had taken weeks since the ending of treatment for my anxiety to really calm down.What's more problematic though is that i am left with a depression that is definitely worse.I have suicidal thoughts, which i never had before.I've lost my passion.Overall i can feel my brain has been overworked from this powerful machine.I'm convinced that this treatment alters the brain in many ways, and is not safe for everyone.I can only pray and try my best to help any damage heal.(b)(4).
 
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Brand Name
NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION MACHINE
Type of Device
TRANSCRANIAL MAGNETIC STIMULATOR
Manufacturer (Section D)
NEURONETICS, INC.
MDR Report Key9451249
MDR Text Key170271153
Report NumberMW5091569
Device Sequence Number1
Product Code OBP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/11/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
B-50; FISH OIL ; SAM-E; TUMERIC
Patient Outcome(s) Disability;
Patient Age35 YR
Patient Weight91
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