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Wednesday, March 13, 2013

Defective Spinal Stimulators: St. Jude Stimulators, Medtronic Stimulators, and Boston Scientific Stimulators May Malfunction by Defective Spinal Stimulator Lawyer Jason S. Coomer

Defective Spinal Stimulators: Implantable Neurostimulation Systems Including St. Jude Spinal Stimulators, Medtronic Spinal Stimulators, and Boston Scientific Spinal Stimulators May Malfunction Causing People with the Devices to Experience a Continuous Shock and Extreme Pain by Defective Spinal Stimulator Lawyer Jason S. Coomer

Defective Implantable Neurostimulation Systems have caused many people to suffer severe shocks, severe pain, and other significant health problems. Persons with or thinking about receiving a St. Jude spinal stimulator, Boston Scientific spinal stimulator, or Medtronic stimulator should speak with their health care provider about the potential health risks of having a spinal 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 from the implanted spinal stimulator are reported to the FDA. For more information on defective spinal stimulator lawsuits, please go to the following web page: Defective Implantable Neurostimulation  System Lawsuit Information or please feel free to send an e-mail to Defective Spinal Stimulator Lawyer Jason Coomer.

FDA Action on Spinal 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.

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.

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.

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