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.
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.