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Abbott Absorb GT1 Bioresorbable Vascular Scaffold Lawsuits

Medtronic Inc.'s Synchromed pump devices are surgically implantable devices meant to deliver medication to an area near a patient's spinal cord. The SynchroMed II drug pump system is used to treat patients who have been diagnosed with cancer, severe muscle spasms, chronic pain, and other serious disorders and who do not respond to oral medications or who have suffered severe side effects associated with oral medications.

More than 200,000 Medtronic SynchroMed devices have been implanted worldwide, according to Medtronic.

As of April 2015, dozens of recalls have been issued over the Medtronic SynchroMed infusion pump system; more than 30 of these recalls have been deemed Class I recalls by the U.S. Food and Drug Administration (FDA). A Wall Street Journal report also found that at least 14 deaths were tied to the system and federal regulators sent a number of warning letters to Medtronic and made several investigative visits to Medtronic's Minnesota manufacturing plant.

Medtronic continues to maintain that, as recently as April 2015, the defective SynchroMed implantable devices need not be removed from the hundreds of thousands of patients who have been implanted with the pain pumps.

Parker Waichman is dismayed at the ongoing lack of action regarding the Medtronic SynchroMed implantable device system and is accepting Medtronic implantable drug pumps lawsuits complaints. Lawyers at our firm who specialize in Medtronic class action lawsuits are offering free legal consultations to individuals who have been implanted with a Medtronic SynchroMed infusion system and who are concerned about potential injuries associated with the device.

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Subject of Class I Recall Over Priming Bolus Failure

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The Medtronic SynchroMed II Infusion Pump line continues to be plagued with issues in recent years that have allegedly led to a variety of individuals to suffer severe and potentially life-threatening health issues.

Medtronic is updating the software for its SynchroMed implantable infusion pumps over a software issue that may cause the pumps to deliver too much or too little of a drug. According to the U.S. Food and Drug Administration (FDA), the SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.

In March 2016, the FDA deemed the Medtronic action a Class I recall. A Class I recall is the agency's most serious designation. According to the agency, "Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority." The Medtronic corrective action was deemed a Class I recall because use of the device involves "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." A recall does not constitute removal of a marketed product. The SynchroMed pumps remain on the market, according to FierceBiotech.

The recall involves Medtronic's SynchroMed EL and SynchroMed II pumps. The pumps are meant to be programmed by a clinician so that prescribed medications are delivered to specific parts of the patient's body.

"Intrathecal drug delivery is an important treatment option for patients with chronic, intractable pain or severe spasticity who have not had success with other treatment options or who experience intolerable side effects with oral medications," said a Medtronic spokesman. The spokesman also stood by the system, despite a history of recalls, serious injuries, and a federal consent decree, saying that, "The SynchroMed II Implantable Infusion System continues to demonstrate strong overall reliability, and Medtronic is confident in its ability to deliver safe and effective therapy."

The SynchroMed II system's pump stores and delivers pain medication by a catheter that is implanted subcutaneously (under the skin). Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure that is used to quickly deliver a large dose of medication from the device to the patient's spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or underdose, which may lead to serious adverse health consequences such as respiratory depression, coma or death, according to the FDA.

Medtronic issued an Urgent Medical Device Correction notice in September 2016 in which the device maker described a software update, description of labeling changes, 8870 software card recommendations, and new priming bolus recommendations. The notice also asked customers to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card.

Medtronic representatives began visiting customers on October 3, 2016 to replace software application cards with updated cards (AAU01), which "mitigates the potential for clinically relevant effects of over-delivery of unintended drug during the full system priming bolus procedure," a Medtronic spokesman said, according to the FDA.

Federal Regulators Issue Consent Decree Ordering Medtronic Inc. to Cease Producing, Distributing, Most Synchromed II Implantable Pump Devices

According to the FDA, Medtronic Inc.'s Synchromed implantable pump devices have been the focus of a number of warning letters issued by the agency over a nine-year period. On April 27, 2015, the FDA announced that, following years of problems that were not corrected by the device maker, Medtronic has been advised that it must stop selling and distributing most of its implantable Synchromed II drug pumps devices. Quality control and manufacturing problems at Medtronic's Minnesota drug pump facility between 2006 and 2013 were cited. The letter noted that the FDA conducted five visits at the site. The proposed consent agreement was reached in collaboration with the U.S. Department of Justice (DOJ) and involved defects in the Synchromed drug infusion pump that had been tied to serious injuries and deaths; allegations that Medtronic's CEO, Omar Ishrak, and its neuromodulation business chief, Thomas Tefft, sold medical devices that did not comply with federal manufacturing standards under the Food, Drug and Cosmetic Act; and claims that Medtronic routinely neglected to correct FDA quality regulation violations. Inspections conducted in 2006 and in 2013 revealed what the government described as "significant violations" of quality regulations, including those concerning complaint handling and corrective and preventive action, which are meant to ensure a malfunction that may potentially lead to injury or death is investigated and that appropriate changes are made, noted The Wall Street Journal.
Under the proposed decree, Medtronic must cease manufacturing and distributing new versions of the SynchroMed II implantable pump.

Reports of Deaths Associated with the Medtronic SynchroMed EL Infusion System

Medtronic Inc. indicates that the SynchroMed EL infusion system, also known as a Medtronic intrathecal pain pump, is an implantable, programmable drug delivery system that uses a catheter to deliver precise amounts of pain medication or intrathecal baclofen (a muscle relaxant and antispasticity agent) directly to the spinal cord's cerebrospinal fluid.

In mid-2013, The Wall Street Journal ran an article about Medtronic's pain pump, noting that 14 deaths had been associated with the SynchroMed infusion system. The majority of the deaths occurred when patients who had been implanted with the device had either gone into withdrawal or overdosed, according to a Medtronic spokeswoman.

Medtronic indicated that it does not recommend patients have the devices removed; patients should, however, contact their physicians immediately if they notice: a change or return of symptoms, or hear an alarm which is designed to sound an alert that the Medtronic SynchroMed implantable infusion pump motor has stalled.

Medtronic also identified four issues with the device, which it communicated to physicians earlier in June 2013, and two that had been previously reported. The U.S. Food and Drug Administration (FDA) classified all four Medtronic pain pump recalls as Class 1 recalls, meaning that the SynchroMed device has the potential to cause serious injury or death.

Medtronic SynchroMed Implantable Infusion Pump Recalls

In August 2007, Medtronic Inc.'s SynchroMed El Implantable Infusion Pumps were the subject of a Class I FDA Medtronic pump recall. According to the FDA recall notice posted on the agency's website in February 2008, one of the pain pump side effects involved the Medtronic SynchroMed El Implantable Infusion Pumps stalling at an unusually high rate, putting patients at risk of serious injury or even death. The FDA only issues Class I recalls when there is a reasonable probability that use of a defective medical device will cause serious injury or death.

Among other issues, some Synchromed devices have been recalled due to loss of battery power. Battery power issues may lead to device failure and, in some cases, the release of too much or too little medication.

The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System. The Medtronic SynchroMed El Implantable Infusion Pump recall involved models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. Only those models with motors manufactured before September 1999 are affected by the recall.

According to the FDA recall notice, Medtronic notified its customers of the SynchroMed pump recall by letter dated August 3, 2007.

The FDA issued a warning letter in 2012 to Medtronic citing the device maker for not correcting problems with the devices, such as the SynchroMed's potential to stall due to motor corrosion and its failure to deliver medication.

As of April 8, 2015, the FDA identified more than 30 Class I recalls associated with the Medtronic SynchroMed infusion pump system, the complete, updated Synchromed pumps recall list is accessible here.

Overdoses, Withdrawal Among the Critical Issues Associated with Medtronic's SynchroMed Pump

Of the reported deaths associated with the Medtronic pain pump, 11 occurred between 1996 and April of 2013; all were attributed to patients being accidentally injected with drugs as part of a medication refill procedure, according to The Wall Street Journal. A blockage that stopped the drug's flow led to two deaths, which occurred between 2007 and February of 2013. An electrical short caused one death, which occurred in March 2013. One of the alleged defects associated with the device is that the SynchroMed pumps lose battery power.

Medtronic responded to the report by sending healthcare professionals recommendations regarding the Synchromed pump-priming mechanism, which may contribute to the risk of improper dosing, while the company indicated that it continues to investigate the issue and determines appropriate product updates.

Another notice, focused on Synchromed pump fails includes the potential for electrical shorts. The notice was sent to patients, urging them to contact their physicians in the event an alarm when the Medtronic infusion pump is in use. At the time the notice was issued, Medtronic did not recommend SynchroMed II pain pump removal unless the system showed signs of malfunctioning. Medtronic estimated that the failure rate was less than 1 percent seven years following implant.

Lawsuits Allege SynchroMed Pumps Caused Permanent Injuries

In 2012 a man brought a lawsuit against Medtronic alleging that a defective SynchroMed pump left him paralyzed. The man alleged that if the device maker had immediately reported manufacturing issues to federal regulators, physicians and patients could have avoided the device and his injury would never have occurred, according to FierceBiotech.

In 2014, the Supreme Court refused to hear Medtronic's request for review in a lawsuit that accused the device maker of negligence and liability over its implantable pain pumps. The device maker was seeking to overturn a lower court's decision that the plaintiff's claims were not preempted under federal law. Preemption, established in the Supreme Court's 2008 decision in Riegel v. Medtronic, protects medical device makers from most liability claims over devices cleared under the FDA's premarket approval (PMA) route, according to Mass Device. The Solicitor General argued that the plaintiff's claims are not preempted as allegations relate to Medtronic's conduct and not with product defects. The Solicitor General asked the court to deny the case, noting that a lower court made the correct decision. In 2013, the Ninth Circuit Court of Appeals ruled against Medtronic. A panel of judges unanimously ruled that a case against Medtronic over its implantable pain pumps may proceed.

According to the lawsuit the plaintiff alleges that, in 2000, he began using the Medtronic SynchroMed EL pain pump. The man began developing signs of paralysis in 2005 due to inflammation in his spine around the catheter tip. Although the device and inflammation were removed they were not removed "in time to prevent the granuloma from rendering" the plaintiff "permanently paraplegic," according to court documents.

In 2016, a Pennsylvania man filed a product liability lawsuit alleging that problems with a Medtronic Synchromed II infusion pump caused him to receive an over-delivery of pain medication, which led to severe and permanent injuries. The lawsuit was filed in the United States District Court for the Middle District of Pennsylvania. Allegations include that the Medtronic Synchromed II was defectively designed and prone to malfunctions that may cause serious medication problems. The plaintiff alleged he had a Medtronic Synchromed II pump implanted in his abdomen in December 2012 to treat chronic pain linked to cervical radiculopathy and cervicalgia. The pump was meant to deliver controlled levels of pain medications into the intrathecal space in his spine. In the summer of 2014, the Synchromed pump allegedly malfunctioned, over-delivering medication, which led to severe pain, nausea, and a lack of mobility that required hospitalization.

Legal Help For Victims Affected by the Medtronic SynchroMed Implantable Infusion Pump

If you or a loved one were injured as a result of a defective Medtronic SynchroMed Implantable Infusion Pump, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) for a free case evaluation by a qualified medical device attorney.


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