How Spine Implants Cause More Harm Than Good
How Spine Implants Cause More Harm than Good Stimulation therapy is a growing treatment intended to relieve chronic pain in the spinal cord by sending electrical pulses through an implant. In some patients, the procedure works well and pain is well-managed. In others, the operation turns dire, causing permanent paralysis. Medical device attorneys at Pintas & Mullins Law Firm look into these implants and who is to blame when a patient is paralyzed. Spinal stimulator devices are manufactured by a variety of companies, including Medtronic, Boston Scientific, and St. Jude Medical. The devices are implanted into patients near the spinal cord, where a pulse generator sends low currents of electricity into extension wires, which are placed on the spine. The leads then transmit an electrical current onto the spine that distracts the brain from recognizing and therefore feeling pain signals. Patients are typically admitted to hospitals for overnight stays, and can return home shortly after implantation with, ideally, a pain-free life. For dozens of patients, the procedure goes too far, causing partial or permanent paralysis or motor weakness. In most of these cases, the injury occurs after the spinal cord is punctured or compressed by the electrical conductors, which are inserted into a narrow cavity called the epidural space in the lower spine (this is where an epidural anesthesia is administered during childbirth). According to the FDAs database, nearly 60 patients were paralyzed by spinal stimulators in 2013 up from nearly 50 the year before. It is worth noting that the FDAs database is far from complete, and many assert that injuries are vastly underreported. Doctors highlight a potential cause of the problem insufficient awareness by doctors on the true risks of operating Continue reading >>
Medtronic Settles $2.8 Million Off-label Suit Over Neurostimulator Promotion
Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company promoted its neurostimulator device for unapproved chronic pain treatment. According to the complaint, originally filed by former Medtronic sales rep Jason Nickell, Medtronic sales staff were directed to sell the device at discounted prices to pain management doctors. Nickell also alleged that sales reps promised physicians could make upward of $10,000 profit on each patient, while adding only minutes to the procedure by using a billing code meant for an FDA-approved use. Neurostimulation provides pain relief byblocking pain messages before they reach the braininstead of pain, patients feel a tingling sensation. According to the complaint, the procedure and intended use of neurostimulation devices at issue, referred to as Sub-Q, subcutaneous targeted neurostimulation (STN), or peripheral nerve field stimulation (PNFS), was a new application of an older device first developed around 2005 and still in an experimental stage as Medtronic was promoting it. The complaint was initially filed by Jason Nickell, a former Medtronic sales rep who, as a Medtronic employee, made $600,000 per year selling the neurostimulation devices. The U.S. later joined in. According to Nickell, he quit his job over concerns about the promotional practices and then filed a lawsuit under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the governments recovery. Nickell will receive $602,000apparently just $2,000 above his yearly salary while selling Medtronic devices. Nickell alleged that during training, his Medtronic mentor would call doctors and encourage them Continue reading >>
Newsroom | Medtronic | Rss Content
Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management The Intellis Platform Includes the World's Smallest Implantable Spinal Cord Stimulator and Offers Personalized Pain Relief and Advanced Activity Tracking DUBLIN - September 18, 2017 - Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the Intellis(TM) platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSM workflow*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs. Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device. "Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. "This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse." Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.1 Chronic pain can negative Continue reading >>
Medtronic Enrolls First Patient In Pain Study To Assess Optimized Spinal Cord Stimulation Programming
Medtronic Enrolls First Patient In Pain Study to Assess Optimized Spinal Cord Stimulation Programming As More Physicians Seek Non-Opioid Treatment Options, the Vectors Study Will Further Advance Understanding of New Approaches to Optimal Spinal Cord Stimulation Treatment DUBLIN - January 9, 2018 - Medtronic plc (NYSE: MDT ) today announced the first patient enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are undergoing spinal cord stimulation (SCS) treatment managed with the EvolveSM workflow*, which standardizes guidance that balances high-dose (HD) and low-dose (LD) therapy settings to help physicians optimize treatment. Evolve runs on Medtronic SCS systems including Intellis(TM), the world's smallest implantable SCS neurostimulator, which recently received U.S. Food and Drug Administration and CE Mark approval. The first patient was enrolled by The Center for Interventional Pain & Spine in Wilmington, Delaware. "Our goal is to improve or restore function. Even with all of today's technological advances, chronic pain can be challenging to manage; this is further complicated by the opioid crisis," said Michael Fishman, M.D., from The Center for Interventional Pain & Spine. "Standard treatment guidance has the potential to help optimize pain relief, and the Vectors Post Market study will provide valuable data about the efficacy of high dose stimulation using standardized programming through the Evolve workflow." The Vectors study is a prospective, multi-center, post-marketing study that will enroll up to 175 patients with chronic intractable pain of the low back and legs at up to 25 sites in the U.S. The study will assess SCS's long-term efficacy and impact on quality of life and was designed to provi Continue reading >>
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Intellis(tm), The Next Generation Medtronic Spinal Cord Stimulator For Long-term Management Of Chronic Pain, Now Licensed In Canada
Intellis(TM), the Next Generation Medtronic Spinal Cord Stimulator for Long-Term Management of Chronic Pain, Now Licensed in Canada BRAMPTON, ON, Aug. 1, 2018 (Canada NewsWire via COMTEX) -- World's Smallest SCS Provides a Non-Opioid Treatment Option for Canadians Suffering from Chronic Pain Medtronic of Canada Ltd., a subsidiary of Medtronic plc MDT, -0.93% today announced it has received a licence from Health Canada for its IntellisTM platform, which includes the world's smallest implantable spinal cord stimulator (SCS) for the management of certain types of chronic intractable pain. Chronic pain is a debilitating condition that can negatively impact all aspects of a person's life -- relationships, work productivity and activities of daily living -- yet it remains under-recognized and undertreated.(1)Given the national crisis involving opioid abuse, it is more important than ever for Canadians suffering from chronic pain to have access to new non-opioid treatment options. "Persistent neuropathic pain is challenging to treat, and our goal should be to restore our patient's mobility and improve their quality of life with effective long-term pain relief," said Sean Christie, M.D., FRCSC, associate professor and director of research at Dalhousie University. "Considering the recommendations of Choosing Wisely Canada(*), it's more important than ever to find effective, long-term, non-opioid solutions. The availability of the Intellis spinal cord stimulator offers new possibilities for some patients struggling with debilitating pain." Who Is Rachel Mitchell, the Prosecutor Tapped for Kavanaugh Hearing? Six million people in Canada report that they have a form of chronic pain.(2) Back problems are among the most common chronic conditions, with an estimated 30 percent of the Continue reading >>
Spinal Cord Stimulation Market Grows As Way To Treat Chronic Pain
Published 10:18 AM ET Thu, 29 March 2018 Connie Hanafy hikes with her daughter Marley. Hanafy was hardly able to walk until she received Medtronic's Intellis spinal cord stimulator. In less than a year, Connie Hanafy went from hiking and rollerskating with her daughters to hardly being able to walk. She had a benign tumor removed from her right leg in January 2017. For months after, she felt pain that didn't make sense. It wasn't typical post-procedure aches. It was a sharp, stabbing, throbbing and crushing feeling rolled up into one. "Before all of this happened, I was an extremely active person. I would hike all the time and was always doing things with my children," Hanafy said. "I was always outside and very outdoorsy. When this happened, it was a huge setback." The 32-year-old hospice worker from New Jersey was diagnosed with complex regional pain syndrome, a chronic condition that can develop after an injury or surgery. She tried treatments like steroid injections, nerve blocks and physical therapy, but the pain continued to worsen. Her only other option was opioid pain pills, but she refused to take them and risk slipping into addiction. By November, she just wanted her leg amputated. Dr. Youssef Josephson of The Pain Management Center in New Jersey suggested she try Intellis, a spinal cord stimulator. The device emits electrical pulses to help treat pain. The Food and Drug Administration had approved Intellis only a few months earlier. It's the latest system from Medtronic , the company that created the spinal cord stimulation market. It's one the medical device maker hopes will better help more patients and turn its performance in the category. Once the market leader, Medtronic ceded ground to rivals, just as the opioid epidemic was putting more focus on alter Continue reading >>
Spinal Cord Stimulator Scs- Any Testimonies?
Spinal Cord Stimulator SCS- Any testimonies? Started by babydollbeck on 08/30/2011 10:46am I have failed back syndrome after 3 surgeries: laminectomy & microdiskectomy, spinal fusion & facet fusion - all at L4-L5. I have DDD, hypermobile joints & chronic pain. This has been ongoing for about 4 years now. A recent MRI showed nothing new. My pain mgmt. doc (whom I trust) has recommended the SCS from Boston Scientific. I have the mandatory psych evaluation this week. If Blue Cross (ugh!) approves the procedure I could be having the trial within a month. I have some reservations but I don't feel I have another choice, save narcotics & misery. We have 2 children & I can't be the wife & mother I should be unless something changes drastically. I have read all the literature on Boston Scientific's website but I would prefer to hear from real people. Please comment if you have personal experience with a Spinal Cord Stimulator or if you know someone who does. Positive or negative, I want to hear about it. Thanks in advance! Hi babydollbeck, just read ur story,,,my name is Rene my story is posted, i have 3 posted ,go to the one w all the replies, the 2 prior postings w my name doesnt have my story i am new to the site and the first two i listed i did incorrectly so there blank. But back to ur issue, yes i highly recommend the stimulater , but not the one that gets inplanted, at my site you will find all the info on what i am using along with my meds. after 3rd day of using this unit along with my med changes, my pain scale has gone from a 200 to a 3. good luck to u, hang in there , there is hope and i hope my posting with my info helps you, let me know what happens and what u think,.. RENE :) Just found your posting regarding Spinal Cord Stimulator from Boston Scientific. I had t Continue reading >>
5 Findings On Spinal Cord Stimulator Effectiveness For Failed Back Surgery Syndrome
5 Findings on Spinal Cord Stimulator Effectiveness for Failed Back Surgery Syndrome Written by Laura Dyrda| May 29, 2014| Print | Email Physicians and researchers recently published an article in Spine about the use of spinal cord stimulation in patients with failed back surgery syndrome. The researchers examined MarketScan data to analyze patients with FBSS who underwent spinal cord stimulation or spinal reoperation from 2000 to 2009. There were 16,455 patients included in the study, with only 395 undergoing SCS implantation. The researchers found: 1. Complication rate was significantly lower at 90 days among the patients who received SCS than spinal reoperation. However, this is hardly the first study to show such results. "Although previous studies have demonstrated superior efficacy for the treatment of FBSS, SCS remains underused," the study authors wrote in the conclusion. "Despite no significant decreases in overall healthcare cost with SCS implantation, because it is associated with decreased complications and improved outcomes, this technology warrants closer consideration for the management of chronic pain in patients with FBSS." 2. Hospital stay was shorter among patients with SCS implantation. The neurostimulation market is one of the fastest growing in medical technology, according to the QiG group . The market was at less than 10 percent penetration in 2012 reaching $2.575 billion as an entire segment with $1.4 billion attributed to SCS but QiG group projected the total segment would reach $4.51 billion by 2016; SCS would reach $2.3 billion. 3. Associated hospital costs as well as overall cost were lower among the SCS group than the reoperation group. The overall cost for the lumbar reoperation group was $82,586, compared with the SCS group that reported Continue reading >>
Mrisafety.com - Info
RestoreAdvanced SureScan MRI, Model 97713 Important note: Each device indicated above is a full-body eligible system if all specific MRI conditions and device requirements are carefully followed. The Medtronic neurostimulation systems used for spinal cord stimulation with SureScan MRI Technology have been specially designed to minimize the potential interactions associated with MRI. These specific spinal cord stimulation systems allow patients safe access to an MRI scan anywhere in the body, referred to as full-body eligible. For Medtronic spinal cord neurostimulation systems with SureScan MRI Technology, external control devices (i.e. a clinician programmer or a patient control device) are used to determine MRI scan-type eligibility and are used to place the neurostimulation system in an MRI conditionally safe (MRI-CS) mode (also referred to as "MRI mode"), which turns stimulation off. If the clinician programmer or a patient control device cannot communicate with the implanted neurostimulation system or if the neurostimulator has reached EOS (end of service), then MRI conditional safety cannot be confirmed via the external control devices. Researching the implanted neurostimulation system configuration from the patient's medical records is required. Unless the implanted system configuration is known and it is determined to be safe to perform an MRI under specific conditions, an MRI scan should not be conducted. Additional conditions apply to ensure safety for patients with spinal cord stimulation systems that have SureScan MRI Technology must be reviewed to ensure patient safety. Please refer to: www.medtronic.com/mri [MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safe Continue reading >>
A Review Of Spinal Cord Stimulation Systems For Chronic Pain
A review of spinal cord stimulation systems for chronic pain We are experimenting with display styles that make it easier to read articles in PMC. The ePub format uses eBook readers, which have several "ease of reading" features already built in. The ePub format is best viewed in the iBooks reader. You may notice problems with the display of certain parts of an article in other eReaders. Generating an ePub file may take a long time, please be patient. A review of spinal cord stimulation systems for chronic pain Paul Verrills, Chantelle Sinclair, and Adele Barnard Spinal cord stimulation (SCS) applications and technologies are fast advancing. New SCS technologies are being used increasingly in the clinical environment, but often there is a lag period between the clinical application and the publishing of high-quality evidence on safety and efficacy. Recent developments will undoubtedly expand the applicability of SCS, allowing more effective and individualized treatment for patients, and may have the potential to salvage patients who have previously failed neuromodulation. Already, high-level evidence exists for the safety, efficacy, and cost-effectiveness (Level III) of traditional SCS therapies in the treatment of chronic refractory low back with predominant limb pain (regardless of surgical history). More than half of all patients with chronic painful conditions experience sustained and significant levels of pain reduction following SCS treatment. Although only limited evidence exists for burst stimulation, there is now Level I evidence for both dorsal root ganglion SCS and high-frequency SCS that demonstrates compelling results compared with traditional therapies. The body of evidence built on traditional SCS research may be redundant, with newer iterations of SCS t Continue reading >>
Spinal Cord Stimulators Paralysis, Adverse Effects
Pain Management Specialist in San Diego & La Jolla In April 2014, the Wall Street Journal published an analysis of adverse events associated with spinal cord stimulators: When Spine Implants Cause Paralysis, Who Is to Blame? These events were submitted to the FDA or were obtained from medical malpractice law suits. In many cases, the injuries occurred after patients spinal cords were punctured or compressed by the stimulator electrodes.The FDAs database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year. The spinal cord stimulators were made by various companies. Researchers at Duke University medical center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal cord or spinal nerve root damage, said Shivanand P. Lad, a Duke Neurosurgeon and the studys lead researcher. The study, based on insurance claim records of 12,300 stimulator patients has been submitted for presentation at an upcoming medical meeting. A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1000, with about 60% of patients eventually experiencing complete or partial recovery. Medtronic updated its product label in February to note that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs. Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers. Stimulators cost between $20,000 and $60,000 each and have estimated global sales of $1.5 billion annually. The FDA Continue reading >>
Fda Approves Spinal Cord Stimulator For Chronic Pain
FDA Approves Spinal Cord Stimulator for Chronic Pain Medtronic plc has announced FDA approval and US launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve workflow which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. It can also record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs. Back problems are 1 of the top 10 most expensive medical conditions, with an estimated 30% of the 300,000 patients annually who undergo lumbosacral spine procedures developing chronic intractable pain. Chronic pain can negatively impact all aspects of a person's life, yet it remains under-recognized and undertreated. Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative. Medtronic plc is headquartered in Dublin, Ireland. Medtronic announces FDA approval and US launch of next generation spinal cord stimulator for chronic pain management. [news release]. Dublin, Ireland: Medtronic plc. September 18, 2017. . Accessed September 27, 2017. Continue reading >>
Cnw | Intellis, The Next Generation Medtronic Spinal Cord Stimulator For Long-term Management Of Chronic Pain, Now Licensed In Canada
World's Smallest SCS Provides a Non-Opioid Treatment Option for Canadians Suffering from Chronic Pain BRAMPTON, ON, Aug. 1, 2018 /CNW/ -Medtronic of Canada Ltd., a subsidiary ofMedtronic plc (NYSE: MDT ) today announced it has received a licence from Health Canada for its Intellis platform, which includes the world's smallest implantable spinal cord stimulator (SCS) for the management of certain types of chronic intractable pain. Chronic pain is a debilitating condition that can negatively impact all aspects of a person's life relationships, work productivity and activities of daily living yet it remains under-recognized and undertreated.1 Given the national crisis involving opioid abuse, it is more important than ever for Canadians suffering from chronic pain to have access to new non-opioid treatment options. The Medtronic Intellis Spinal Cord Stimulation (SCS) device and platform for treatment of chronic intractable pain. (CNW Group/Medtronic of Canada Ltd.) "Persistent neuropathic pain is challenging to treat, and our goal should be to restore our patient's mobility and improve their quality of life with effective long-term pain relief," said Sean Christie, M.D., FRCSC, associate professor and director of research at Dalhousie University. "Considering the recommendations of Choosing Wisely Canada*, it's more important than ever to find effective, long-term, non-opioid solutions. The availability of the Intellis spinal cord stimulator offers new possibilities for some patients struggling with debilitating pain." Six million people in Canada report that they have a form of chronic pain.2 Back problems are among the most common chronic conditions, with an estimated 30 percent of the patients that undergo lumbosacral spine procedures developing chronic intractable pain Continue reading >>
Medtronic Launches Next-gen Spinal Cord Stimulator For Chronic Pain Management
Medtronic Launches Next-Gen Spinal Cord Stimulator for Chronic Pain Management Includes world's smallest implantable spinal cord stimulator; offers personalized pain relief and advanced activity tracking. Medtronic's Intellis Spinal Cord Stimulation Platform. Image courtesy of Medtronic. New 510(k) Approach Would Leverage FDA Objective Criteria Medtronic plc announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSMworkflow, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs. Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device. "Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. "This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse." Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.1Chron Continue reading >>
Medtronic Rolls Out Latest Device To Treat Pain With Electricity
Medtronic rolls out latest device to treat pain with electricity New device delivers current to block pain. With medical device companies across the nation hustling to find ways to treat pain without addictive opioid drugs, Medtronic is launching a system called the Intellis that uses electricity and can be securely controlled with a Samsung tablet. The Intellis is a latest-generation spinal-cord stimulation system that uses electric pulses to prevent pain signals from reaching the brain. The system was designed with features that address issues with older devices, including a new design that allows patients to fully recharge the device battery in one hour, and an interface that lets a doctor use a Samsung Galaxy S2 tablet to quickly adjust device settings and view past performance. "The Intellis platform was designed based on what is most important to patients and physicians," Dr. Marshall Stanton, president of Medtronic's pain therapies division, said in a news release. More than 20,000 Americans a year die from overdoses of prescription pain drugs, a toll that has shifted public attention toward ways of treating pain without creating addiction. Last May, Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote online that his highest priority is to take immediate steps to reduce the scope of the opioid addiction epidemic. Implanted medical devices offer some promise in that regard, and a potentially large commercial market, but pain-relief devices also have their own drawbacks, including the need to charge batteries and the difficulty in adjusting device settings in response to subjective pain sensations. Medtronic competitor Abbott Laboratories, which acquired Minnesota-based St. Jude Medical and its line of devices to treat chronic pain in January, has w Continue reading >>
