Thursday, May 2, 2013

St. Judes EON Back Stimulator Adverse Events Include Burning, Pain, Disability and Required Intervention By Texas St. Judes Eon Back Stimulator Lawyer Jason S. Coomer

St. Judes EON Back Stimulator Adverse Events Include Burning, Pain, Disability and Required Intervention By Texas St. Judes Eon Back Stimulator Lawyer Jason S. Coomer

Defective St. Judes EON stimulators can cause catastrophic injuries, impairment, and the need for revision surgery.  Patients considering a spinal implant should review the FDA's adverse event reports and discuss potential problems with their health care provide prior to having surgery or implants.

When investigating defective St. Judes Eon Back Stimulator lawsuits, it is important to know what implant had been used as well as to obtain medical records of the surgery.  For more information on Defective St. Judes EON lawsuits, please feel free to send an e-mail message to defective St. Judes EON lawyer Jason Coomer.

St. Judes EON Back Stimulator FDA Adverse Event Reports

Several different adverse events have been reported to the FDA regarding St. Judes EON Back Stimulators including a few of them which are listed below.  For patients that have had bad experiences with St. Judes EON Back Stimulators, it is import to make sure that these adverse events are reported to your health care provide and the FDA.  

Model Number 3851ANS
Event Date 07/15/2012
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Event Description

An eon ipg spinal cord stimulator generator implant was inserted on (b)(6) 2012. On (b)(6) 2012, upon recharging the unit, client experienced pain and a burning sensation at the implant site. The client immediately stopped the recharging process at that time. On (b)(6) 2012, the client tried to recharge the unit once again and she immediately felt a burning discomfort at the implant site. She stopped the charge and reported to the surgeon's office. A company representative from st. Judes got in contact with the pt and provided her with a new charging unit on (b)(6) 2012. The pt proceeded to recharge on this date, however, this time the pt experienced severe pain with charging. Pt is scheduled to have the generator removed on (b)(6) 2012. Diagnosis or reason for use: rsd - used for pain relief.

Model Number 3851
Event Date 05/21/2012
Event Type  Injury   Patient Outcome  Disability
Event Description

The stimulator does not work as intended. Intermittent, and gets heated when charging. The stimulator shuts off periodically, when turned on, it beeps 2x then shuts off. The device has to be turned on and started over. The device has to be turned up 1 bar at a time for strength. After 4 bars, the unit shuts down. Doctors stated that it needed to scar in, st judes reps and stated it will work. Now almost a year out, this device still does not work, has had a revision of the scs, and moved a level down. It still stimulates the abdomen and causing severe stomach pain. The ipg has been reprogrammed by st judes reps many times and still does not work as expected. On (b)(6) 2011, stimulator implanted. On (b)(6) 2011, stimulator turned on and activated. Every 2 weeks after that i was up at the doctors office having it readjusted, still doesn't work. Around (b)(6) 2012 had revision done. Still didn't work. Worked intermittently and shut off. Stimulating abdomen more than any other part of back causing severe stomach pains. (b)(6), i had 14 screws and 5 rods removed from back as st judes reps and doctor thought that it might have been interfering with the pulse signals. Still to this day, (b)(6) 2013. The device still does not work correctly. Dates of use: (b)(6) 2011 - (b)(6) 2013.

Model Number 3788
Event Date 01/04/2013
Event Type  Malfunction 
Event Description

Per the surgeon - failed occipital nerve stimulator; possible defective generator and/or lead. The surgeon removed and replaced the occipital nerve stimulator and lead. ======================manufacturer response for spinal cord stimulator, spinal cord stimulator generator (per site reporter). ======================rep took the device for evaluation.

Model Number 3788
Event Date 09/02/2010
Event Type  Malfunction   Patient Outcome  Other
Manufacturer Narrative

Eval method: the device history and sterilization records were also reviewed. Results: the device history and sterilization records were reviewed and were found to meet specs and no anomalies were found. Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records. Ans has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported. Ans defers to the pt's physician regarding medical history.

Event Description

On (b)(6) 2010, the pt was implanted with an scs system. The pt states that her system will turn off randomly. This has happened many times over the last several months. While it is off, she is not able to communicate with her ipg via the programmer. Her system will then turn back on by itself. When it turns back on, it comes on with a strong surge and then reduces to the normal stimulation level. After it turns back on, she is able to communicate with the ipg via the programmer again. The pt has not tried to communicate using the charger during a time when the stimulation was off. This problem does not appear to be position related or happen at any specific time of day. Diagnostic impedances all came back normal. The pt was reprogrammed over 6 times and all programs had the same results. The clinical specialist was never preset during a period when the stimulation was off. The doctor has decided to replace the ipg. 

Model Number 3788
Event Date 02/04/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

Method: device history and sterilization records were reviewed. Results: the device history and sterilization records reviewed were found to meet specs and no anomalies were found. Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records. Ans has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported. Ans defers to the pt's physician regarding medical history.

Event Description

On (b) (6) 2008, a pt with rsd of the right foot was implanted with dual percutaneous leads. It was reported that the pt complained of over stimulation. On (b) (6) 2010, the dr replaced the percutaneous leads with a surgical lead. The percutaneous leads did not have any irregularities and were functioning fine. The leads had migrated into the gutter and the pt was receiving over-stimulation. On the evening of (b) (6) 2010, it was reported that the pt was at home and felt severe over stimulation/shocking. The pt fell out of their chair and to the floor. The pt reported the symptoms were similar to a "seizure. " it took about 5 minutes before the pt was able to call 911. The emt was able to turn off stimulation with the magnet. Emt stated pt was drenched from sweat from his neck down and his hands were curling in, as if having a seizure. On (b) (6) 2010, the clinical specialist (cs) met with the pt at the hospital. Diagnostic impedance showed contact 8 was high. X-ray verified the connections were intact and that the lead may have moved left. Programs 1-6 for the previous percutaneous lead were removed so the pt could not inadvertently use the old programs.

Patients with Serious Back Injuries Including Severed Spinal Cords, Crushed Discs, Bulged Discs, and Herniated Discs when Seeking Pain Relief can sometimes Fall Victim to Defective Products, Negligent Health Care, and "For Profit" Medical Professionals Seeking to Increase Profits: Be Careful When Deciding to Have Back Surgery

The human spinal cord is basically a bundle of nerves which is surrounded by 33 bones or vertebrae.  Located between each vertebrae is a spinal disc which is a liquid filled disc shaped pouch.  These discs are stacked on top of one another and act as shock absorbers allowing the spine to flex, bend, and twist.  When functioning properly, the vertebrae and discs protect the spinal cord allow nerve impulses to travel from and to the brain to other parts of the body.  This allows us to experience sensations, move our bodies, and control many bodily functions.

Problems arise when the vertebrae, discs, or spinal cord are injured.  Broken vertebrae can damage and impinge on discs or the spinal cord causing extreme pain, numbness, and loss of control of bodily functions.  Back injuries can occur through traumatic events that result in paralysis.  Depending where and how severe the injury is will determine what type and how severe the paralysis is.   

The human body has remarkable healing potential.  Combining determination, proper medical attention, knowledge about an injury, and focus on the healing process can greatly help most injuries.  Hiring a lawyer to battle the insurance companies and responsible parties can allow the injured person to focus on the healing process.     

If you or a loved one have suffered a traumatic spinal cord injury or other serious back injury including a severed spinal cord, broken vertebrae, crushed discs, herniated discs, or a bulged discs; the most important thing you can do is to find a good medical doctor to assess the injury so you know what you are dealing with and how to best treat the injury.  From physical therapy and steroid injections to back surgeries (lumbar diskectomy, cervical fusion, and other lumbar or cervical procedures), there are many different ways to treat a back injury and it is important to know what will work best for you.  

Unfortunately, there are also medical clinics, medical implant sales people, and doctors that are more interested in profit and their bottom line than what is best for a patient.  Some of these medical professionals carelessly cause painful and difficult conditions to become much worse by paralyzing patients that are seeking relief from pain.   

As the economic pressures of the medical system keep pushing medical providers to become "for profit" and prioritize making money over the health of individual patients; unnecessary procedures, overworked staff, using defective products, and making mistakes will become more common and hurt people.  It is extremely important to thoroughly investigate any clinic, hospital, surgeon or other health care provider prior to having spinal surgery, or any other complicated procedure.  Please feel free to go to the following web pages for more information on Failed Back Surgery and Defective Implantable Neurostimulation System Lawsuits, Texas Medical Malpractice Lawsuits, and Federal Medical Malpractice Lawsuits.

11 comments:

  1. Of course many treatments methods are available to treat back pain but I think physical therapy is more effective and safe than others to solve this problem.Physical therapy

    ReplyDelete
  2. Thank you for sharing. If you're looking for ways to regain and/or keep your health using a holistic medical approach, it's time you sat down with a chiropractor.
    chiropractic Beverly, MA

    ReplyDelete
  3. Have Surgery scheduled on Nov 4, 2013 to remove EON SCS that has not worked correctly since it was implanted Nov 4, 2008. Though trial was fantastic the unit never did work correctly after a reprogramming incident where I was severely shocked it never stimulated except in my guts not a good feeling.

    ReplyDelete
    Replies
    1. I hope your procedure went well and wish you a speedy recovery. I am scheduled for perm. spinal nerve stimulator placement next week. The trial gave about 50% relief. The trial only lasted 2 days because the leads moved and when turned on it started at the highest level and I had to adjust down. The stimulus was so strong it was like I was hooked up to 220v with legs contracted straight out. Ouch... but it looked cool.

      Would you do it again?

      Thank you

      Delete
  4. Thank you for sharing your experience. We have heard similar issues from several people and am sorry that you have had to endure significant pain and multiple surgeries. We wish you the best with your surgery as well as your recovery.

    ReplyDelete
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  6. I received the implant 2-4-14, so far, I haven't had any substantial relief, I am told it is because I haven't developed any scar tissue yet. They cannot seem to get the stimulation to get where it is needed, my left side ribcage. I opted to not take any more of the Percocet to see if it the unit was doing me any good. It's not! I met with the St. Jude rep and now I am told that my 'scar tissue' may take 3-6 additional months BEFORE the unit does it's job. Does any of this ring true?

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  10. I was implanted with what just found out was a "RECALLED AT TIME OF SURGERY" in 2013.( St Jude Eon Mini Model 3701). The Registration information is with my units recharging case, and it appears the Hospital section was never sent in. I guess that is why I never was informed about a recall even later. I have had problems with this unit from 6 months when it went dead after shocking me very badly. Have complained to D.O. that implanted it and had unit evaluated several times. They agreed it was dead, and needed replaced. They never mentioned it was recalled. No one did. I remember even asking if it was recalled due to defects. This was my second charging system implant and first one lasted about 4 years. (different system) I have had to mention replacing this bad unit now and again when I go to my pain doctor visits every 3 months, now it is May 2017. I know for a fact that My Doctor has submitted for approval to DOL/OWCP to remove or replace the bad unit several times, and never said anything to me about a recall. For about 3 months and now I am desperate. The site where the battery is is shocking/burning me out of the blue. It is like I am trying to get away from ***, but can't. That is why I looked up the model to see if it had any defects with battery acid leaking, because that is what I think is going on with my implant. It is so severe that if it doesn't quit or simmer down, I would need to go to the ER and have this thing cut out of me!!! But thank goodness, it does eventually simmer down to a controllable pain level. My P.A. at the Pain Clinic gave me shots to the site, that helped a little. As it is a radiating pain originating from the battery site. But I am having continual pain at the site now for the last three months of degrees levels 4/10-10/10 on a pain scale. I am just wondering if anyone else had recalled implants implanted. Is this common practice. Whose fault is this. My Pain D.O. Reps. from St Jude Medical for the implant programming. Shouldn't they of said something about this? It has taken so long for the replacement most likely due to this being a workers comp case, but with it being a recall, shouldn't St Jude's pay for the replacement or to take it out and that should of happened when I first complained about it having problems and going dead!! I just want this thing out of me! I imagine St Jude would say that the Doctor should pay to take it out since he put it in after the recall.. Fat chance of that happening, and I now more understand why no one has said anything to me. They would be admitting guilt, and opening themselves up for liability. Agree?

    ReplyDelete