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 2012-04-04 for NEUROSTAR TMS manufactured by Neuro Star.

Event Text Entries

[2620498] Transcranial magnetic stimulation by neurostar used (b)(6) 2010, 5 times/week for 6 weeks, 1 hour per session. (b)(6) noted to have clear manic episode, first in pt's history. No new medications during that time. No life changes. Dates of use: (b)(6) 2010. Reason for use: treatment resistant depression.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024977
MDR Report Key2532422
Date Received2012-04-04
Date of Report2002-04-04
Date of Event2011-04-07
Date Added to Maude2012-04-13
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNEUROSTAR TMS
Generic NameTRANSCRANIAL MAGNETIC STIMULATION
Product CodeOBP
Date Received2012-04-04
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerNEURO STAR


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-04-04

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