Brenda Keough
January 9, 2010 01:55 AM

RE: Medtronic Spinal Column Stimulator malfunctioned causing electrocution 1998-2008
Hi, I'd like to know if anyone is advocating for the people the government uses experimentally, leaving us forgotten when they pay for a medical device spinal column stimulator from Medtronic Canada that doesn't get any follow ups, no check up after electrocution. ________________________________________ From: bkeough [mailto:keough63@sympatico.ca] Sent: Saturday, January 09, 2010 4:14 AM To: 'andrewsteinberg@lawyer.com' Subject: To whom this May Concern Jan 9, 2009 FDA January 8, 2009 Attention: To whom this May Concern, This information is going to the FDA and hopefully they will listen and learn of an injured worker lost in a medical system, given little choices after an accident at work in 1985- that led to silent medical madness and a Medtronic stimulator that was implanted and forgotten about for 25 years. I have proof that before this 25 year nightmare I worked had a life was making my mark....and the past wasn't used against me, I'd forgotten..... Exonerate ME for WSIB to see what others missed and I found the hard way http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm I came across this information and need to know, as well as advise you of issues I've been through twice facing serious adverse health consequences and almost death, at the hands of a stimulator WSIB paid 3 times to implant, undergoing 5 operations yet WSIB only shows 3 operations, because 2 were fixing botched issues.....not a soul knows anything medically about why they had it implanted in an injured workers body when their reports asked for no consent from me, or even explained to me what I would go through..... I worked for the Federal M.P., and that was where my second malfunction took place and had a co-worker not been in the same room. I would have died from the malfunctions that happened with the Medtronic's Pisces in 1998 and Quad X-trel in 2008 that were inserted and forgotten not followed up on to find out how this first experimental device was working for the patient and how the patient is working with the new changes of having a machine in my body that due to misdiagnoses and neglect from those who couldn't see the facts, has cost me interruptions for 5 years of rebuilding my life in silence. Telling doctor's what happened but not being understood, followed up with or thrown out of hospitals, because they knew nothing about the machine and seem scared to come near me. The Medtronic law suit is being done for the heart defibrillator and because now I'm being told since the first implant in 1991....that this is the first implant put in the area of the upper body. I never did anything, nor thought I should do anything about the previous malfunction, all I knew it helped 50 percent cure the nerve damage pain; burring and spasms...caused by a neglected broken rib in 1985....the result being the rib-removed along with callus and damaged nerves. This operation had to be done in haste, only because everyone else wasn't going to remove the rib, they experimented on me to find ways to stop the pain......WSIB's file shows this in black and white, yet, the malfunctions and follow-ups have never been asked for. I was forgotten....and I forgot about the pain and memories of the past ignorance, ego, or abuse that could have and should have been avoided. I can't explain enough to WSIB about the malfunctions and reports were not written by these doctors who ignored the malfunctions implications paralyzing my whole system unable to speak, cry out only cry because the electricity was increasing higher than my programmed locked in device that I wear 24/7. I worked out that morning before going to work with the machine on, if it had to be the disc moved as Medtronic said it was it would never have gone outside the parameters of the locked in mode. Tell me what to do next, where do I go, I've been forgotten since 2001, by the surgeons who were supposed to do follow-up, WSIB should have followed up, or should know how long the machine will last, and when it should be removed, but I am the only one with that information and I sent them an email showing them the information I found on line, this machine has been turned off, I was told it was obsolete without parts and since 2005, and I was not notified? I'm looking for someone that won't do any further damage, take this failed device out of my body......if anyone else is wearing this...then recall it because it could kill them My system is turned upside down and I've deteriorated greatly....I have wished for death, because of what was done, what was taken, what was ignored, but God didn’t want me yet. I know I would have died had this gone up anywhere else, nobody knew about the machine, nobody asked and I didn’t have to say anything. I sit here daily since 2008, in a new place renting with a friend, because I could no longer afford to live by myself, or take care of myself. Financially, I’ve been ruined. Mentally, psychologically I have been devastated by the loss most of all by the children I’ll never get to see, and knowing WSIB adjudicator gave that issue no report, nor did they give me time to grieve the loss. They took away any chance of ever having a child by agreeing to pay for a machine that was not thoroughly investigated enough to warn me of any ongoing issues with being shocked to death. I don't want to die, but since the second electrocution, my depression, anger and pain have increased, the burning in the nerves never lets up. When I wore the machine it was later noted by Medtronic when it was sent back to them for repair/investigation that I ran on 750 amps. That was a great deal of vibration, but it helped since 1991, the first one, a Pieces II lasted for 8 years, malfunctioning at my new job of 8 years, that lead to me being shocked, taking time off work and having increased pain to deal with. I was not made aware of any problems nor did I have time to check this out. The time it took for an operation after that incident caused me untold terror and depression. I was operated on by the same surgeon who didn’t freeze me enough, sedate me enough and I went through hell in the operating room, squirming and crying, only to hear him tell me to stay still, or he would stop the operation. I had to scream for more sedation, I was given so much that I went under and he didn’t test the machine before sewing me up, I woke up in recovery with him reprimanding me for the scene in the operating room. I cried too much to fight. When I got back home, and recovered, I tried the stimulator, only to realize that he had put the electrode in the wrong place. His words to me that morning were, “which leg are we operating on,” as all his patients have leg issues. That was what he did, put electrodes on the wrong nerves and caused severe vibration to go down my legs, which caused me to fall, unable to walk properly as my legs were locked up by vibration. When I notified Dr. Tasker, and saw him, he seemed angry that I was asking for help. He sat across from me with arms folded and asked me to walk. He tried to adjust the stimulator, but was not able to raise the voltage to my upper back where it was suppose to work, when it was turned up, it affected my walking to the point I couldn’t walk. He didn’t do an x-ray, for he would have seen what the other doctor’s saw. My doctor received a letter from him saying that there was nothing he could do, and that I had a choice to live with “paralysis or pain.” That wasn’t a choice seeing the machine was successful working on the nerve pain for 8 years. He refused to help, I had to seek out other surgeons who verified that there was a problem with the electrodes, but they wouldn’t touch me, due to Dr. Tasker being in practice. It took me a year to find another surgeon, someone who was not associated with Dr. Tasker, I never told him the story behind the disabling pain, I didn’t want to, I wanted to get this machine fixed and return to my job, my life, He did an x-ray and found a difference comparing it to the 1991 x-ray and said he would fix the electrodes. After 1998, I didn’t see, or hear from Dr. Vanderlinden until 2002. My doctor tried calling, writing, faxing, but he was not returning a call. My health was deteriorating, I had fallen at home, hitting my head, waking up on the concrete floor it a concussion, and damage to the nerves on the right side of my face, I saw my doctor, she took pictures of my bruises, and I had to go on morphine the pain had reached it’s peak. WSIB fought constantly with me not believing I had a problem, not approving what the doctor asked for and questioning everything I did, or said. My doctor’s husband finally took it upon himself to go out to the surgeons office and managed to get a date for surgery. He had to fight with the secretary, before seeing Dr. Vanderlinden, but he voiced his concerns about his office not returning calls, faxes or having the surgery done in 1998 as he had said. If it wasn’t for my doctor and her husband, I wouldn’t have pulled through that time. I lived alone, finally reaching out to the community centre for help in my apartment. WSIB wouldn’t do a thing and still fought with me when I requested taxis to get to my doctor appointments. It was explained to WSIB that the stimulator was not working properly, but they gave no relief. I was asked by my adjudicator to measure the distance from the apartment to the bus, when I called in tears to get them to approve a taxi, so I could go to my doctor. We had to be trained by Medtronic representative to work with the stimulator trying to get it to work in the upper back, but nothing could be done. Medtronic did nothing about investigating the malfunction, or explaining how I could be severely affected by the shock that I couldn’t move to save myself. Same as in May 2008, I sent my machine to them, and they sent me a loner, I wouldn’t use it too afraid of what had been done. I left my new job and was reinstated to WSIB in December 2008. Still, my adjudicator gave me problems, saying that I wasn’t disabled enough. Once again, I lost and still lose, because I can’t go out much, can’t do much of anything, can’t sleep more than 2 hrs a night, can’t seem to have the instinct to eat food, or taste it, can’t focus, and can’t remember as much as I use to. My mind is no longer my own. I finally had the operation in 2002, Dr. Vanderlinden moved the wires back to the right place, unfortunately, he too put me under completely, not testing the machine, and when I turned on the stimulator, I realized it still was too far away from the issues I dealt with and wasn’t helping. I had to have another operation two weeks later. Since 2008, I have been living in fear of this infecting me, or having to have 1/2 an operation because the neurosurgeon is incapable of removing the whole device. I need it all out to find out how this could malfunction....WSIB manager sent out a report to the Board, it was an update on me. The report said that I suffered from “low back issues, and caused nothing but complaints and problems for WSIB. Nobody even bothered reading my file. It’s too thick for one thing, but it has no medical updates from a surgeon for them to understand the severity of my neglected medical issues since the 1985 accident at Parr Ind. All I want now is someone to give me some peace. I cannot be expected now after having the wiring in my upper back from the first surgery 17 years ago nor do I want to go through 2 separate surgeries, because everyone is tired of what they don't know or is not reporting. How can I after all these years explain what WSIB can't understand, because they didn't ask for a neurosurgeon’s prognosis, or ask for updates the machine. They have nothing in my medical file relating to this machine to tell them anything so they could understand my health issues...through the years when they should have? My body has scars and pain that remind me, I'm still in hell and will have to endure another operation to have this antiquated machine removed, investigated and my body be noted for the mess I can't explain because nobody would see me until it was way past the point.....the only difference being, I've deteriorated beyond my own will...in front of other peoples eyes, and WSIB won't and don't understand even when I told them the hell I went through. Thank you all for your time. This will be my last request for assistance in clearing the past mistakes away, and changing my medical future by 2010. According to the Fair Practice Commission, it's a medical issue that WSIB cannot intervene in, yet, how are they assessing my disability since these invisible atrocities have not been mentioned in my WSIB report. The Government is using a device that cures pain. I can attest to this, but it almost killed me, and WSIB wants a doctor to say that in their report before they'll believe it, because I couldn't get medical attention until I started losing more of my life. I've waited through procedural processes, and had a meeting with WSIB in 2006 because of the derogatory misleading information that is in my file....and still in 2009, the person I mentioned the electrocutions to the day it happened....has the gall to send out a report on issues that happened in 2005 06 that my reports that went to the WSIB proved, yet nobody wants to look into my file...it's unbelievably messed up by judgments that WSIB claims I suffer from. I am coming out of silence and ending and finally putting to rest this character assignation that have followed me since the misdiagnosis in 1985, only because this nightmare like 1998 is happening again, I'm losing ground, as well as what was once a wonderful mind. My nervous system and body have been turned upside down, I lost my sight in November due to the onset of cataracts that went unnoted by WSIB...and nobody cares it was done by a machine they were not fully informed of, nor cared to hear about from me. Sorry, doesn't mean a thing from those that can't grow outside the box and face a new ultimately ugly issue, or medical negligence, and inhuman behavior, only because I was alone, through this, lost much, because of this......and had to rebuild each time with faith when I got to work and got off the system that is a concentration camp that has raped my mind and body, humiliated me without offering me a chance to prove what I finally found out from 3 new neurosurgeons I've just recently seen.. They finally explain they've never seen such an issue or injury of where my rib was, and can't do the operation on the top of my spine, only remove the transmitter. Why is that? There are many hospitals that have no backup in their understanding what I just learned from my second surgeon who is now retired, yet, playing with my life again. This machine is NO LONGER ON THE MARKET AND I WAS NOT ADVISED, NOR DID WSIB ASK FOR DETAILS AS A REMINDER TO PROTECT ME FROM GOING OUTSIDE THE LIFE EXPECTANCY.....and it's because of so few doctors that I'm alone through this now. I finally had the machine taken out November 13, 2009. I asked the Neurosurgeon Dr. Vanderlinden to give me everything that was in my back, he gave me the transmitter which looks like it’s in the corrosive stage. I didn’t receive the leads, but was also told by him that he had to take a piece of bone out of my spine as the machine had been imbedded in my spine. I am without a stimulator now, no longer trusting, but none the less, I still need help with the burning in the nerves and a complete neurological checkup. My body and mind are no longer in my control, due to the electrocutions, medications, rage and anger over what has happened to me since my accident. I want to put this to rest, get compensated for 6 operations and the damage that has befallen me since 1985 due to negligence. The attachments are the information I’ve found in my medical file. I had a meeting with WSIB June 06, because I found a report from one of WSIB doctors saying “this 63 year old lady suffers from low back issues. I’ve only been seen to suffer from low back, nothing noted by WSIB that they understand the pain I’ve been in since the rib/nerve removal, 2 malfunctions and 6 operations that is not listed the adjudicator only listed 3 operations? Nothing is listed about the 2 children I lost, and the fact that WSIB paid for something that was inserted in my body that was already traumatized by the long wait to show them I had a physical issue. It took 11 months and a list of doctors and medicine during that time to find someone to help me, in the end I went to Dr. Pearson who removed the rib, with a letter that said I had enough and if I was sent away, I wouldn’t bother living in this hell I was forced to live with daily. Before my accident, I didn’t have any issues physically, or mentally. I had a job of 6 years working with my boyfriend of 14 years, had a social life, was doing upgrading for a GED. Each time this machine malfunctioned I was the only one losing, if someone wasn’t around to unplug the device from the transmitter, I would be dead. Both occasions 1998 & 2008 my life was saved by my co-workers, because my body was contorting and completely paralyzed, my chest hurt and my heart was beating so fast during the 10 minutes I had to endure this malfunction I wore this machine 24/7 and it helped with my pain to the point I didn’t need medication, yet I’m called an addict in my files at WSIB and many more labels followed me. Without choices, without hope for years, not months to get the machines fixed, and taken out I have been incarcerated in my home, not able to get out, not able to live and lost my rebuilt lives each time, my career and my financial security. I won’t lose again, I’ll find alternative modalities for dealing with the nerve damage and pain, but I won’t rest until this silent nightmare is fully investigated and I am fully compensated for the added injuries to my mind, soul and body, those responsible for the calamity and neglect held accountable for their inhuman behavior. Brenda Keough 19 Hart Ave Scarborough, ON M1K 3H2 647-298-3587 Cc: Doug Christie Dr. M Weiner Mr. P. Silverman