RECLAIM DEEP BRAIN STIMULATOR FOR OCD. SOLETRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for RECLAIM DEEP BRAIN STIMULATOR FOR OCD. SOLETRA manufactured by Medtronic.

Event Text Entries

[85148794] Dear sir or madam, listen to the attached videos of dr. (b)(6). In his own voice he admits committing (b)(4) fraud, fabricating a diagnosis that did not exist so he could commit the (b)(4) fraud and also violate the false claims act. He and the (b)(6) did this and many, many more criminal and unethical violations against me over many years. I have dedicated a (b)(4) page to the crimes committed against me and now my life is in danger and i can find no justice. I have not received my requested medical records from the (b)(6) that i have been trying to obtain since 2011. I have contacted (b)(4), senators, congressmen and many other government agencies and gotten no help. I also requested that my medical records be forwarded to a doctor for additional medical attention. I was told by dr. (b)(6) my records had been sent. I emailed the doctor i was requesting to be seen by and he said he had received nothing. I then contacted dr. (b)(6) of the (b)(6). He told me earlier he was sending my records to the doctor i had requested medication attention. Dr. (b)(6) told me he would not release my records without a court order. Dr. (b)(6) and the (b)(6) prevented me from receiving medical help that they refused to render. On (b)(6)2013 the (b)(6) sent me a letter saying they would remove, for free, a fraudulently implanted medical device called the reclaim deep brain stimulator for obsessive compulsive disorder (implanted in (b)(6) 2010) and remove a coil of a vagus nerve stimulator (implanted in 1998 which cause me to pass out). I had surgery in 1999 to remove the entire vagus nerve stimulator and was told about a year later that a coil was left of the left vagus nerve of my neck. I was angry that i had been lied to and it took till (b)(6)2013 for (b)(6) to remove the coil. Five minutes before being prepared for surgery the surgeon, dr. (b)(6), came to me in the waiting room and told me the removal of the coil was dangerous. I told him at least 3 times that if there was any chance i could be harmed to leave the coil alone and only remove the reclaim deep brain stimulator for ocd. Dr. (b)(6) decided to remove the vagus nerve stimulator coil and cut the left vagus nerve. The effects have altered my life by making all of my organs function improperly. My heart stops several times daily, my lungs have never worked properly since the surgery, i choke on water and food every day and my g. I. System has not functioned properly since the surgery. I have to have ivs many times due to dehydration and malnutrition. The reclaim deep brain stimulator for ocd and the opioids (90mg oxycodone per day) and many other drugs that dr. (b)(6) had me addicted to make dr. (b)(6) orchestrate a fraudulent emergency involuntary commitment to the (b)(6)'s psychiatric ward where i was horribly mistreated, denied an attorney, guardian ad litem, rendered unconscious for 3 days by the use of drugs to sedate me, denied clothing, visitors and no consent was given. Dr. (b)(6) did the commitment to cover the illegal implantation of the reclaim deep brain stimulator (because of the mania and suicidal side effects of the medical device). He also used the 3 days to try to receive my addiction to the oxycodone. During and after the emergency involuntary commitment dr. (b)(6) threatened to have me put in a mental institution for an indefinite period of time and the (b)(4) were ordered to invade my home at 2:00 am. All of this is on my (b)(6) using (b)(6)'s documents and recordings of dr. (b)(6). Dr. (b)(6)and the (b)(6) conspired with judge (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071983
MDR Report Key6845534
Date Received2017-09-06
Date Added to Maude2017-09-06
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRECLAIM DEEP BRAIN STIMULATOR FOR OCD.
Generic NameRECLAIM DEEP BRAIN STIMULATOR FOR OCD.
Product CodeOLM
Date Received2017-09-06
Model NumberSOLETRA
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-06

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