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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURONETICS INC. NEUROSTAR TMS; TRANSCRANIAL MAGNETIC STIMULATOR

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NEURONETICS INC. NEUROSTAR TMS; TRANSCRANIAL MAGNETIC STIMULATOR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Pain (1994); Seizures (2063); Loss of consciousness (2418); Patient Problem/Medical Problem (2688)
Event Date 02/02/2019
Event Type  Injury  
Event Description
Seizure - fell to floor; i was receiving transcranial magnetic stimulation (tms) to treat depression at (b)(6) health under dr (b)(6).The (b)(6) attendant, (b)(6), left before the first cycle.When i realized that there was something wrong (that the tms helmet was not on correctly), i screamed in extreme pain for help, as my arm moved uncontrollably, feeling like it was ripping off.I then lost consciousness.But no one came in response to my screaming or my collapse.After the procedure was scheduled to be over, (b)(6) returned to the room and found me on the floor.He called for ems.This happened once before and the tech readjusted the helmet and my arm stopped moving.Showed broken down muscle indicate of a seizure.Also evidence i had bit my tongue.Fda safety report id# (b)(4).
 
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Brand Name
NEUROSTAR TMS
Type of Device
TRANSCRANIAL MAGNETIC STIMULATOR
Manufacturer (Section D)
NEURONETICS INC.
MDR Report Key9653836
MDR Text Key177547167
Report NumberMW5092669
Device Sequence Number1
Product Code OBP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age21 YR
Patient Weight64
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