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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS THYMATRON; ELECTROCONVULSIVE THERAPY DEVICE
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SOMATICS, LLC SOMATICS THYMATRON; ELECTROCONVULSIVE THERAPY DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Memory Loss/Impairment (1958)
Event Date 01/01/2002
Event Type  Injury  
Event Description
I had 187 ect's.I complained of memory loss often but was told it was only temporary and would return.It hasn't in the last 18 years.I've been waiting but feel i was deceived by both the mfr and my drs who were improperly told my memory would return.I had 179 ect's between 2002-2003 and 8 in 2005, since i had already lost my memory and my depression / mania (bipolar) would not respond to any of the treatments.All were performed at (b)(6).I'm on disability prior to treatment, 1998, so (b)(6) paid out at least (b)(6) at (b)(6) / treatment (that's the low end of the averages).I feel i should be compensated, a lot.I cannot even remember my two children's births.Living without a memory is extremely difficult, like having alzheimers and knowing it.Please stop the mfr somatics from harming others.Loss of all long term memory.Please help.Two companies make this.Fda safety report id# (b)(4).
 
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Brand Name
SOMATICS THYMATRON
Type of Device
ELECTROCONVULSIVE THERAPY DEVICE
Manufacturer (Section D)
SOMATICS, LLC
MDR Report Key9524944
MDR Text Key173206855
Report NumberMW5091900
Device Sequence Number1
Product Code GXC
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 12/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age38 YR
Patient Weight113
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