NEUROSTAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for NEUROSTAR manufactured by Neuronetics, Inc..

Event Text Entries

[77634156] Caller would like to raise awareness that there may be more side effects than advertised. He started treatment (b)(6), and continued five times a week, for 2 weeks. Side effects included, short-term memory loss, fear, panic, confusion, auditory hallucinations, intensified migraines, anxiety, worsened depression, agitation, and anger. Caller has discontinued use of product and returned to previous psychiatrist. Medication adjustments were made to counteract side effects and verbal therapy sessions were increased.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5070381
MDR Report Key6639538
Date Received2017-06-13
Date Added to Maude2017-06-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
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
Generic NameTMS
Product CodeOBP
Date Received2017-06-13
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEURONETICS, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-13

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