TMS NEUROSTAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for TMS NEUROSTAR manufactured by Neuronetics Inc..

Event Text Entries

[50236754] My son (b)(6) was approved for tms treatment through his psychiatrist, after 8-10 sessions he started feeling worse, more depression, more anxiety, more irritable, they said this could happen (only after he started treatment did they say this could happen, no mention before) he continued treatment and continued to get worse. He stopped tms at 18 sessions as the insurance would no longer approve payment since he was getting worse. My concern is that it was not disclosed that it could negatively impact his depression and i see others have experienced the same outcome. Neurostar is the maker of the tms device and i have reached out to them as well to report the feedback. I feel further testing/investigation may be needed before using this device on people already in a fragile state with depression, only to make it worse. My son wants to die and we both truly feel we would not have done the treatment if we would have known this was the outcome or there was even a chance it could make things worse.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063555
MDR Report Key5811741
Date Received2016-07-18
Date Added to Maude2016-07-21
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 FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTMS NEUROSTAR
Generic NameTMS NEUROSTAR
Product CodeOBP
Date Received2016-07-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNEURONETICS INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-18

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