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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURONETICS NEUROSTAR TMS NEUROSTAR TMS

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NEURONETICS NEUROSTAR TMS NEUROSTAR TMS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Depression (2361); Sleep Dysfunction (2517)
Event Date 01/13/2016
Event Type  Injury  
Event Description
Had a procedure call transcranial magnetic stimulation. The device made me sick, worsened my depression to the extent i couldn't move my body or function anymore. It gave me body pain all over which i never had. I've gained 60lbs because i had to go on medications. I was a working person and can't work anymore because i can hardly move my body. I had to go on disability. I was medication free before treatment. It caused total insomnia. Had to go onto powerful meds in order to sleep and not feel like i was going to die. It's now almost 2 year later. Neurostars website who make the tms machine says it's symptom free or insomnia. Anxiety, weakness, fatigue, nausea. This is a lie. I'm not the only one who has gotten worse from this treatment. There are entire forums of people who got worse from this treatment. They cannot post on their website lies about what it does not cause. I've lost my life from this treatment. "what is the fda going to do about it. " ref report numbers mw5067012 and mw5074918.
 
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Brand NameNEUROSTAR TMS
Type of DeviceNEUROSTAR TMS
Manufacturer (Section D)
NEURONETICS
MDR Report Key6961147
MDR Text Key89861525
Report NumberMW5072838
Device Sequence Number1
Product Code OBP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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