NEUROSTAR TMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for NEUROSTAR TMS manufactured by Neuronetics.

Event Text Entries

[89861525] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072838
• MDR Report Key: 6961147
• Date Received: 2017-10-19
• Date of Report: 2017-10-17
• Date of Event: 2016-01-13
• Date Added to Maude: 2017-10-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NEUROSTAR TMS
• Generic Name: NEUROSTAR TMS
• Product Code: OBP
• Date Received: 2017-10-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEURONETICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2017-10-19