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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINSWAY LTD. BRAINSWAY SREPETITIVE TRANSCRANIAL MAGNETIC TIMULATION 120 % MOTOR THRESHOLD; BRAINSWAY DEEP TMS SYSTEM
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BRAINSWAY LTD. BRAINSWAY SREPETITIVE TRANSCRANIAL MAGNETIC TIMULATION 120 % MOTOR THRESHOLD; BRAINSWAY DEEP TMS SYSTEM Back to Search Results
Model Number 102B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Loss of consciousness (2418)
Event Date 12/09/2015
Event Type  Injury  
Event Description
Participant had a generalized tonic clonic seizure during the administration of ther first rtms session at full strength (120% of mt).The seizure lasted about a minute and the participant lost consciousness, but not control of bowels.The rtms was discontinued and the participant was brought to the emergency room via ambulance.She was evaluated in the emergency room and discharged to home.Dose of amount; 20hz, frequency 55 trains and route 120% mt, 1980 pulses/session.Dates of use: phase 1 (sham) (b)(6) 2015, event stopped: doesn't apply and phase 2 (active) (b)(6) 2015; event stopped after use: yes.Major depressive disorder.
 
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Brand Name
BRAINSWAY SREPETITIVE TRANSCRANIAL MAGNETIC TIMULATION 120 % MOTOR THRESHOLD
Type of Device
BRAINSWAY DEEP TMS SYSTEM
Manufacturer (Section D)
BRAINSWAY LTD.
19 hartum st.
bynet bldg., 3rd fl.
har hotzvim, jerusalem 97775 18
IS  9777518
MDR Report Key5306158
MDR Text Key33839283
Report NumberMW5058561
Device Sequence Number1
Product Code OBP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number102B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
Patient Weight54
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