• In June 2013, Medtronic, Inc. initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. (asahq.org)
  • The SynchroMed Implantable Infusion System continues to demonstrate strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy," the company said in a statement. (drugwatch.com)
  • Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. (fda.gov)
  • The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. (asahq.org)
  • It consists of small pump or reservoir that is surgically located under the skin of the abdomen and transports medication through a catheter to intrathecal space or subarachnoid space. (clickpress.com)
  • During ITB therapy, an implantable, programmable pump ( SynchroMed II , Medtronic) delivers a continuous baclofen injection ( Lioresal Intrathecal , Medtronic) by way of the newly approved Ascenda catheter. (medscape.com)
  • The pump is placed no more than 2.5 cm beneath the skin, and the catheter is then connected to it. (medscape.com)
  • Long-term continuous intrathecal baclofen (CITB) infusion is a treatment option used to manage otherwise intractable spasticity and is delivered via an implantable pump. (nih.gov)
  • Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. (drugs.com)
  • For instance, in November 2014, Tricumed Medizintechnik GmbH launched the implantable, programmable infusion pump for baclofen therapy. (abnewswire.com)
  • Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. (fda.gov)
  • The SynchroMed Implantable Infusion Pumps are being recalled because of the unintended delivery of drugs during the priming bolus procedure. (asahq.org)
  • During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus. (asahq.org)
  • These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after an MRI exam). (blogspot.com)
  • Many modern insulin pumps have a "bolus wizard" that calculates how much bolus insulin is needed, taking into account expected carbohydrate intake, blood sugar level, and still-active insulin. (wikipedia.org)
  • when administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. (curehunter.com)
  • Rise in burden of chronic disease, growing geriatric population, technological advancements, high demand for infusion pump, and rise in adoption of smart infusion pumps are major factors expected to boost the growth of the global infusion pump market. (coherentmarketinsights.com)
  • This report provides in-depth analysis of the global infusion pump market, and provides market size (US$ Billion) and compound annual growth rate (CAGR %) for the forecast period (2023-2030), considering 2022 as the base year. (coherentmarketinsights.com)
  • It profiles key players in the global infusion pump market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies. (coherentmarketinsights.com)
  • The global infusion pump market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts. (coherentmarketinsights.com)
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global infusion pump market. (coherentmarketinsights.com)
  • The most common issue was accidental injection of a pain medication directly into the patient's tissue instead of the pump. (drugwatch.com)
  • Infusion pumps are used to deliver fluids into a patient's body in a controlled manner. (coherentmarketinsights.com)
  • An infusion pump is a medical device used to deliver fluids, such as nutrients and medications, into a patient's body. (coherentmarketinsights.com)
  • In order to obtain the pump, a treating physician must certify that a SynchroMed II pump is medically necessary for a patient's treatment, according to the Justice Department. (yourlawyer.com)
  • Implantable infusion pumps may be used to treat chronic pain, muscle spasticity, and many other diseases or conditions. (holidayhealth.com)
  • The pump is used to treat pain in patients who cannot take oral medication, have severe spasticity or intractable pain, by delivering drugs directly to cerebral spinal fluid. (drugwatch.com)
  • Remodulin is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion and is administered in a clinical setting. (rxlist.com)
  • single-shot epidural or intrathecal opioids may serve as an indicator to the future success of continuous infusions or patient-controlled analgesia using opioids. (slideserve.com)
  • Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size. (fda.gov)
  • Places a pacemaker or an implantable cardioverter defibrillator (ICD) in the chest to correct your heartbeat. (medlineplus.gov)
  • An implantable cardioverter defibrillator (ICD) to help prevent sudden cardiac arrest . (medlineplus.gov)
  • Aetna considers intra-hepatic chemotherapy (infusion) medically necessary for members with liver metastases from colorectal cancer. (aetna.com)
  • MRI Technologists, Radiologists, Surgeons, MRI Prescribers and Implantable Infusion Pump Managers can review the recommendations released by the FDA here . (holidayhealth.com)
  • The FDA is informing patients, caregivers, MR technologists, and health care providers of important safety precautions to help patients with implantable infusion pumps safely have an MRI exam. (blogspot.com)
  • FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. (ahrq.gov)
  • These agents are used in resistant cases as intravenous infusions and stimulate beta1-adrenergic receptors in the myocardium. (medscape.com)
  • The specific conditions that health care practitioners and patients should follow before, during, and after an MRI exam varies by the make and model of the implantable infusion pump system. (holidayhealth.com)
  • Health care professionals and patients in the US are encouraged to report adverse events or side effects related to the use of any implantable infusion pump to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-3321088. (holidayhealth.com)
  • Patients were treated with combined chemotherapy of epirubicin (EPIR), mitomycin C (MMC), 5-fluorouracil (5-FU), by hepatic infusion using a subcutaneously implanted reservoir. (nih.gov)
  • However, the MR environment presents safety hazards for patients with implantable infusion pumps. (blogspot.com)
  • Two of the patients died because of a pump blockage and another died from an electrical short, the company said. (drugwatch.com)
  • Patients using the pain pump have few options for treatment, according go the Star Tribune. (drugwatch.com)
  • Most of my patients, if I told them I wanted to take their pump out because of potential problems, they would say, 'Leave it in until you know for sure,' " Chappuis told the Star Tribune. (drugwatch.com)
  • That is not to say that some patients don't have a problem or two with their pump. (drugwatch.com)
  • Other pumps released too much or too little medication, endangering patients. (yourlawyer.com)
  • The Justice Department press release explains that SynchroMed implantable drug pumps are prescribed for patients with cancer, chronic pain and severe muscle spasms who do not respond to oral medications or who experience severe side effects when taking such medication. (yourlawyer.com)
  • Third, the United States alleged that Asfora solicited and received kickbacks from medical device manufacturer Medtronic USA Inc. in exchange for using its SynchroMed II infusion pumps, which are implantable devices used to deliver medication to patients. (imperialvalleynews.com)
  • The intrathecal drug delivery pump is a method of giving medication directly to the spinal cord to stop pain signals from being perceived by the brain. (clickpress.com)
  • The implanted pump delivers an infusion of the drug solution to the area surrounding the spinal cord. (yourlawyer.com)
  • This medicine is delivered by a drug pump directly into the spinal fluid of your back. (drugs.com)
  • Radiantinsights.com includes Global Spinal Pumps Market Report Review To Their Database Up To 2024. (abnewswire.com)
  • The global spinal pumps market is expected to reach USD 319.8 million by 2024, according to a new report by Grand View Research, Inc. The rising geriatric population base, which is highly susceptible to developing chronic disorders, such as cancer as well as movement and neurological disorders, leading frequently to subsequent spasms and pain, is presumed to propel the need for spinal pumps. (abnewswire.com)
  • These statistics indicate the indisputable requirement to incorporate spinal pumps, which is expected to present the industry with lucrative growth opportunities. (abnewswire.com)
  • Furthermore, the growth of the spinal pumps market is attributed to the technological advancements and the expanding product pipeline comprising pump volume indicators, valve-regulated pumps, and pressure monitors. (abnewswire.com)
  • The pain management category dominated the application segment of the overall spinal pumps market in terms of revenue share at over 69.0%in 2015, owing to the increasing preference for long-term relief alternatives and the high prescription prices associated with conventional opioid drugs used in pain management. (abnewswire.com)
  • These aforementioned factors are responsible for the high adoption rate of spinal pumps in pain management. (abnewswire.com)
  • Moreover, the subsequent demographic trend changes, such as the increase in the elderly population count, and the high awareness levels related to the availability of highly efficacious pain management solutions including the spinal pump devices are presumed to drive the industry growth in this region. (abnewswire.com)
  • Additionally, the rising number of government initiatives focusing towards the enhancement of the existent healthcare infrastructure, for instance in China, the healthcare reforms introduced through an initiative, the New Health Care Reform Plan, implemented by the Chinese State Council and the Central Committee of the Communist Party of China (CPC), serve as the key growth contributing factors towards the growth of the regional spinal pumps market of China. (abnewswire.com)
  • Insulin pumps are used to deliver insulin on a continuous basis to a person with type I diabetes. (wikipedia.org)
  • Insulin pumps make it possible to deliver more precise amounts of insulin than can be injected using a syringe. (wikipedia.org)
  • Insulin pumps can provide an accurate record of insulin usage through their history menus. (wikipedia.org)
  • On many insulin pumps, this history can be uploaded to a computer and graphed for trend analysis. (wikipedia.org)
  • There are reports of alleviation or even total disappearance of resistant neuropathic pain with the use of insulin pumps. (wikipedia.org)
  • Recent studies of use of insulin pumps in Type 2 diabetes have shown profound improvements in HbA1c, sexual performance, and neuropathy pain. (wikipedia.org)
  • José Gadea discusses the use of implantable pumps as an alternative to serial injections when administering compounds to laboratory animals. (insidescientific.com)
  • Abe C, Tashiro T, Tanaka K, Ogihara R, Morita H (2009) A novel type of implantable and programmable infusion pump for small laboratory animals. (springer.com)
  • Implantable infusion pumps for continuous administration of test agents to unrestrained laboratory animals. (alzet.com)
  • Intrathecal pumps are a category of analgesic infusion pumps that deliver medication into the individual's body for pain management. (clickpress.com)
  • Technavio's analysts forecast the global intrathecal pumps market to grow at a CAGR of 4.27% during the period 2016-2020. (clickpress.com)
  • The report covers the present scenario and the growth prospects of the global intrathecal pumps market for 2016-2020. (clickpress.com)
  • Technavio's report, Global Intrathecal Pumps Market 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. (clickpress.com)
  • In addition, the rising involvement of the industry players in the development of treatment solutions through strategic alliances is likely to present the intrathecal pumps market with a potential growth platform. (abnewswire.com)
  • According to the Justice Department, the pumps were not manufactured in accordance with current good manufacturing processes and some SynchroMed pumps deliver either too much or too little medication. (yourlawyer.com)
  • A doctor will surgically place the pump and monitor the dose of the medication that is delivered by the pump. (drugs.com)
  • Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size. (fda.gov)
  • The drug is stored in the pump reservoir. (fda.gov)
  • SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size) and SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size). (asahq.org)
  • A traditional pump includes: the pump (including controls, processing module, and batteries) a disposable reservoir for insulin (inside the pump) a disposable infusion set, including a cannula for subcutaneous insertion (under the skin) and a tubing system to connect the insulin reservoir to the cannula. (wikipedia.org)
  • This can happen if the pump battery is discharged, if the insulin is inactivated by heat exposure, if the insulin reservoir runs empty, the tubing becomes loose and insulin leaks rather than being injected, or if the cannula becomes bent or kinked in the body, preventing delivery. (wikipedia.org)
  • The market is driven by a number of factors such as the increasing incidence of chronic diseases along with the rapid growth of the geriatric population, rising demand for outpatient infusion pumps, and increasing volume of surgical procedures. (globalmarketstudies.com)
  • The intrathecal pumps delivery method can minimize chronic pain and trauma caused by several chronic diseases such as cancer and multiple sclerosis. (clickpress.com)
  • 3) Use of lidocaine or xylocaine for analgesia prior to use of a vascular access device of an implantable infusion pump. (pacodeandbulletin.gov)
  • Buchwald describes the roots, heritage, and traditions of this remarkable period at the University of Minnesota's medical school, where the foundations of open-heart procedures, heart and pancreas transplantation, bariatric surgery, implantable infusion pump therapies, and other medical landmarks originated. (umn.edu)
  • Surgeons may use off-pump heart surgery to do coronary artery bypass grafts (CABG), but only in certain cases. (medlineplus.gov)
  • The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. (fda.gov)
  • An infusion set is tubing that delivers insulin from an insulin pump to the body and typically requires a set change every two to three days. (coherentmarketinsights.com)
  • An implantable infusion pump is a device that is surgically implanted under the skin, typically in the abdominal region. (holidayhealth.com)
  • Implantable infusion pumps are devices that are surgically implanted under the skin, typically in the abdominal region. (blogspot.com)
  • The US Food and Drug Administration (FDA) has received reports of serious adverse events - which includes patient injury and death, associated with the use of implantable infusion pumps in the MR environment. (holidayhealth.com)
  • The U.S. Food and Drug Administration found four flaws with the pump and in late June issued a Class I recall - the most serious recall it can give - because of the potential for life-threatening complications. (drugwatch.com)
  • Despite years of warnings from the Food and Drug Administration (FDA), Medtronic Corp. failed to correct problems with its SynchroMed infusion drug pumps, and now the Justice Department has taken legal action to halt the sale of the pumps. (yourlawyer.com)
  • Implantable drug-eluting devices (also referred to as implantable drug delivery systems) offer several unique advantages over conventional oral or parenteral drug delivery methods. (drug-dev.com)
  • 3) The refilling of implantable drug delivery systems following placement by a physician in the proper anatomical site. (pacodeandbulletin.gov)
  • Heart failure - when your heart is too weak or stiff to pump enough oxygen-rich blood to meet your body's needs. (medlineplus.gov)
  • Some medical devices, including some implantable infusion pumps, can be affected by the strong magnetic fields associated with MRI. (blogspot.com)
  • These pumps are small-sized implantable infusion devices. (clickpress.com)
  • Though it's not a complete list, Reuters reported that DHS Industrial Control Systems Cyber Emergency Response Team, or ICS-CERT is looking at a Hospira infusion pump, and implantable heart devices from both Medtronic and St. Jude Medical, as well as medical imaging and networking equipment. (thecre.com)
  • Fresenius Kabi can provide both dedicated infusion sets for our infusions systems and also a range of general IV disposables suitable for a range of clinical applications. (fresenius-kabi.com)
  • Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in the home. (coherentmarketinsights.com)
  • Only implantable infusion pumps labelled as MR Conditional may be used safely within a Magnetic Resonance (MR) environment, and only under the specified conditions of safe use. (holidayhealth.com)
  • Be aware that MRI exams may affect the function or programming of your infusion pump, even when the specified conditions of MR Conditional use have been followed. (holidayhealth.com)
  • Only implantable infusion pumps labeled as MR Conditional may be safely scanned, and only under the specific conditions of safe use. (holidayhealth.com)
  • An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. (wikipedia.org)
  • An insulin pump is an alternative to multiple daily injections of insulin by insulin syringes or an insulin pen and allows for flexible insulin therapy when used in conjunction with blood glucose monitoring and carbohydrate counting. (wikipedia.org)
  • Infusion with or without additional dopamine in renal dose would be appropriate therapy for cardiogenic shock secondary to dilated cardiomyopathy. (medscape.com)
  • If you have an implantable infusion pump, it may be a safety hazard for you to undergo an MRI exam. (holidayhealth.com)
  • Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an Magnetic Resonance Imaging (MRI) exam. (holidayhealth.com)
  • and other mechanical problems with the pump such as the motor stalling, and the pump not restarting after an MRI exam. (holidayhealth.com)
  • Bring the implant card for your implantable infusion pump with you when you go for your MRI exam. (holidayhealth.com)
  • Before you can safely have an MRI exam, your health care team will need to identify your specific pump model to locate the specific MRI safety information for your pump. (holidayhealth.com)
  • If there are any questions about the make and model of an implantable infusion pump you have, contact the physician who manages your pump and do not have the MRI exam until the specific implantable pump model is identified. (holidayhealth.com)
  • The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall. (asahq.org)
  • Doctors must administer some of these drugs as injections or infusions, while people can take others orally. (medicalnewstoday.com)
  • Possibility of insulin pump malfunctioning, and having to resort back to multiple daily injections until a replacement becomes available. (wikipedia.org)
  • Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. (fda.gov)
  • The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. (fda.gov)
  • Include information to notify medical professionals that you have an implantable pump and that MRI precautions need to be followed. (holidayhealth.com)
  • Medical device manufacturer Medtronic, which is already embroiled in litigation about a synthetic bone graft product it makes, also produced a pain pump linked to 14 deaths, according to Bloomberg. (drugwatch.com)
  • If this initial dose cannot be tolerated because of side effects, the infusion rate may be reduced to 0.625 ng/kg/min. (rxlist.com)
  • Many users feel that bolusing insulin from a pump is more convenient and discreet than injection. (wikipedia.org)
  • For example, your implantable pump may need to be checked and/or reprogrammed by your physician before and after your MRI. (holidayhealth.com)
  • Dr. Christian Schnell describes his work involving implantable infusion pump studies in rodents and the advancement of pharmacological interventions in oncology research. (insidescientific.com)
  • Click here for a complete list of all of the compounds that have been delivered via ALZET pumps. (alzet.com)
  • Due to the mechanism by which ALZET pumps operate, compounds of any molecular size can be delivered predictably at controlled rates, independent of their physical and chemical properties. (alzet.com)
  • Evidence of the successful use of ALZET pumps for delivery of these compounds is found in the scientific literature. (alzet.com)
  • More recent models may include disposable or semi-disposable designs for the pumping mechanism and may eliminate tubing from the infusion set. (wikipedia.org)
  • Therefore, pump users typically monitor their blood sugars more frequently to evaluate the effectiveness of insulin delivery. (wikipedia.org)
  • The company notified customers that flaws in the device may affect the safety and reliability of the delivery of medicine from the pump. (drugwatch.com)