MAUDE Adverse Event Report: NEURONETICS NEUROSTAR TMS; NEUROSTAR TMS

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.

• Brand Name: NEUROSTAR TMS
• Type of Device: NEUROSTAR TMS
• Manufacturer (Section D): NEURONETICS
• MDR Report Key: 6961147
• MDR Text Key: 89861525
• Report Number: MW5072838
• Device Sequence Number: 1
• Product Code: OBP
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 116