NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION manufactured by Neuronetics Inc..

Event Text Entries

[145082499] I was a couple of weeks into treatment and i complained about central nervous system and cognitive related issues. I could feel my nerves, began having hand tremors, was having cognitive issues, my depression was getting worse, and i was complaining of anxiety symptoms getting worse. The staff insisted that this is all normal or 'unrelated' after consulting with the supervising physician. The treatment itself was advertised to me as safe with minimal side effects and a less than 1% chance of a seizure. They claimed no other pts reported my experiences. We continued treatment and as my health declined, they maintained that the treatment could not cause it. They actually extended treatment beyond the fda approved guidelines and implemented tms treatment for 12-13 wks. My symptoms became so bad that i lost work, had to obtain financial support from the government and family, and had to seek add'l medical treatment. Months later, i am still recovering with much financial and health consequences. The misleading statements, the extended treatment, and disregard for my health is what is motivating me to prevent tms from being misused again and harming other pts. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086569
MDR Report Key8604639
Date Received2019-05-10
Date of Report2019-05-08
Date of Event2018-11-05
Date Added to Maude2019-05-13
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 NameNEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION
Generic NameTRANSCRANIAL MAGNETIC STIMULATOR
Product CodeOBP
Date Received2019-05-10
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEURONETICS INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2019-05-10

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