Spine Stimulator Lawyer: Implantable Neurostimulation Systems
Including St. Jude Stimulators, Medtronic Stimulators,
and Boston Scientific Stimulators May Malfunction Causing Pain and Requiring Removal by Spine Stimulator Lawyer Jason S. Coomer
Several Implanted Spine Stimulators have malfunctioned including locking on and failing to work causing significant pain and many situations additional surgeries to repair or remove the implanted stimulators. Persons with or thinking about receiving an implanted
spine stimulator, should speak with their health care provider about the
potential health risks of having a spine stimulator implanted in them
as well as make sure that the device is being used for an FDA approved
indication.
Persons that have experienced severe shocks, malfunctioning batteries, and other problems with an implanted spinal stimulator, should consult their health care provider and make sure that any adverse health events are reported to the FDA. For more information on spine stimulator lawsuits, please go to the following web page: Defective Spine Stimulator Lawsuit Information or please feel free to send an e-mail to Spine Stimulator Lawyer Jason Coomer.
Implantable Spinal-Devices Are a Multi-billion Dollar Industry and
the Leaders In the Industry Are Medtronic, St. Jude Medical, and Boston
Scientific
Implantable Neurostimulation Systems and other spinal-devices are a huge
business for the medical implant device industry. The global market
for spinal-devices is currently over $ 3 billion per year and is
expected to increase to over $5 billion per year by 2018. Currently,
the major manufacturers in the neurostimulator market are
Medtronic, St. Jude
Medical, and Boston Scientific.
Neurostimulators have been used for a variety
of types of chronic back pain situations including heriniated disks,
postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk
surgery, Degenerative Disk Disease, and Failed Back Syndrome. The
Medtronic implantable neurostimulation system is indicated for spinal
cord stimulation (SCS)
as an aid in the management of chronic, intractable pain of the trunk
and/or limbs—including unilateral or bilateral pain associated with
several different conditions. Unfortunately, because of the profits to
be made from implanting a spinal stimulator, many people have received
spinal stimulators for off-label or non-approved indications.
Medical professionals that are aware of significant off-label use of spinal stimulators are encouraged to properly report any Medicare fraud or Medicaid fraud that may be occurring. Please feel free to go to the following web page for information on Qui Tam Whistleblower Reward Lawsuits and Reporting Medicare Fraud.
FDA Action on Spine Stimulators
The U.S.
Food and Drug Administration (“FDA”) issues warning letters when
it finds certain problems that it wants a company to fix. In a
letter dated July 17, 2012, the FDA issued a warning letter
related to Medtronic’s process for handling complaints and
stated that regulatory action might ensue should the
manufacturer fail to address the agency’s request to take
action. The FDA also issued a warning letter to St. Jude
Medical, resulting in the company’s announcement that there were
weld failures present within the internal batteries of their
units. Physicians and Patients who may have been implanted with
defective stimulators are being notified individually by St.
Jude Medical. Since the problem surfaced in 2011, over 300
heat-related complaints have been filed on behalf of carriers of
defective units and several lawsuits have been filed.
The failure of a stimulator to operate correctly has had many
effects on our clients. At a minimum, defective devices expose
clients to the very pain the devices are supposed to relieve. In
addition to increased pain, other symptoms our clients have
reported experiencing include:
- Severe irritation and burning at the battery site
- An inability to control the stimulator (resulting in unwelcome jolts, pain, or temporary paralysis)
- Severe burns while recharging the battery
- Premature battery depletion
- Bladder problems
- Increased numbness
- Lead migration and broken anchors
- Partial paralysis
In most cases, when a stimulator is found to be defective it
must be removed. This surgery can be both costly and cause its
own complications. Not only is there always a risk of infection
with every surgery, but because the removal of a stimulator
requires navigating delicate nerves in the spine, it is possible
that nerves can be nicked or otherwise damages during the
procedure leading to symptoms such as weakness, pain, or
numbness in the body. In some cases, removal of the simulator
can result in a leakage of spinal fluid from the epidural space,
leading to severe and long-lasting headaches or feelings of
fatigue which may heal on its own or may require its own surgery
to repair.
Spinal Stimulator Lawsuit Information
In reviewing potential failed back surgery implant lawsuits, it is
important to obtain copies of your medical records and to determine if
the implantable neurostimulation system was
properly implanted by the spinal surgeon or if the spinal stimulator
was defective. If the spinal stimulator was defective and has/had to be
removed, it is important that the defective device is kept as potential
evidence. For more information on this topic, please feel free to go
to the
following web page, Failed Back Surgery and Defective Implantable Neurostimulation System Lawsuits or please feel free to send an e-mail to Defective Spinal Stimulator Lawyer Jason Coomer.
