Medtronic Device Recalls, Alleged Defects May Result In Lawsuits
National law firm Parker Waichman LLP has successfully represented individuals for decades who suffered injuries and losses due to medical device defects. The firm is investigating potential lawsuits over injuries suffered due to Medtronic’s medical devices.
Medtronic Devices the Subject of Numerous Recalls
Medtronic devices have been on the market since 1988-1999 and have been the focus of increasing scrutiny in recent years. In early 2017, a Medtronic recall was deemed a Class I by the U.S. Food and Drug Administration (FDA). The recall involved software associated with the SynchroMed Implantable Infusion Pump. A Class 1 recall designation is the most serious FDA classification.
According to the agency, “Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.” A Class I recall represents “ 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.”
The SynchroMed II and SynchroMed Implantable Drug Infusion Pumps are programed to deliver prescribed medications to a specific site within a patient’s body. Generally, prescribed drugs are deployed to the patient’s spine.
Meanwhile, the FDA deemed another Medtronic recall a Class II in May 2008. The recall was implemented following reports of shaft wear and potential misconnections involving the Medtronic Sutureless Connector (SC) catheters from the pump’s catheter port. The Medtronic Neuromodulation INDURA IP recall was prompted by the potential for life-threatening blockages.
A Class II recall designation involves “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the agency.
In 2009, Medtronic recalled pacemakers marketed under the Kappa and Sigma brand. That same year it recalled the MiniMed Paradigm insulin pumps. Also in 2009, the FDA indicated that Medtronic took too long to recall its SynchroMed II pumps. The FDA also advised Medtronic that the device maker was aware of deficiencies at its manufacturing facility in Puerto Rico approximately two years prior to the recall issued May 2008.
In 2012 Medtronic issued a safety communication to its customers concerning the potential for a two-fold rate of device failure should unapproved drugs be used with their SynchroMed pumps.
By 2015, after the agency issued dozens of letters to Medtronic concerning an array of issues with its Synchromed pumps, the regulator initiated a manufacturing ban on the Medtronic SynchroMed II Implantable Infusion Pump Systems.
Medtronic Quick-Set Infusion Sets
In July 2009, Medtronic initiated a recall of one lot of Quick-Set infusion sets because the devices might not vent properly. This defect could interfere with the infusion set’s ability to deliver insulin to patients diagnosed with diabetes, leading to serious injury or even death. The recall involved Medtronic Inc.’s MiniMed Paradigm insulin pumps. The devices defect could cause either too much or too little insulin to reach the patient’s blood stream, which may lead to catastrophic adverse events. If you or someone you know were/was injured because of one of these devices, our Medtronic Quick-Set infusion set recall lawyers want to hear from you.
Medtronic’s Quick-Set infusion set is a thin plastic tube used to deliver insulin from the MiniMed Paradigm insulin pump to a diabetes patient. The device is typically replaced by the patient every three days. Medtronic announced that it had discovered that approximately two percent of Lot 8 Quick-Set infusion sets may not allow the insulin pump to vent air pressure properly. This may potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. Patients were told to stop using the Quick-Set infusion sets from Lot 8 immediately.
Medtronic indicated that its investigation of the venting problem revealed that a lubricant clogged the vents in some of the affected Quick-Set infusion sets. To resolve this situation, the lubricant has been eliminated from the manufacturing process.
The Quick-Set infusion sets involved in this recall bear reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” The lot number (for example 8XXXXXX) is clearly marked on the product box label and on each infusion set package. Lot 8 Quick-Set infusion sets were distributed in the United States, and in limited quantities to a small number of countries outside of the United States. The list of countries affected by this recall is available at www.medtronicdiabetes.com/lot8 or by contacting any Medtronic country office. No other Medtronic devices or infusion sets are involved in this recall.
Customers were asked to return any affected infusion sets to Medtronic, which also sent impacted customers with replacement Quick-Set infusion sets at no additional charge. Medtronic indicated that it mailed out notification letters to customers, as well as one million replacement sets, which represents a 30-day supply.
A defective Quick-set infusion set could cause a MiniMed Paradigm insulin pump to deliver too much or too little insulin to a diabetic patient. Insulin is a hormone naturally produced by the pancreas that enables the body to use the sugar in food as a source of energy. Diabetics do not produce enough insulin, which makes it impossible for their bodies to regulate blood sugar.
If a defective Quick-Set infusion set causes the delivery of too much insulin, insulin overdose may occur. Symptoms of an insulin overdose include very low blood sugar levels (hypoglycemia), headache, irregular heartbeat, increased heart rate or pulse, sweating, tremor, nausea, increased hunger, and anxiety. In very extreme cases, insulin overdose may lead to death.
Too little insulin may an cause symptoms of high blood sugar (hyperglycemia), including confusion, drowsiness, rapid breathing, fruity breath odor, increased urination, or unusual thirst. If hyperglycemia is not treated, a life-threatening condition known as ketoacidosis (diabetic coma) might occur.
SynchroMed Pump and Infusion System Lawsuit Alleges Medtronic Aware of Deficiencies
In 2010, an Arizona couple brought a lawsuit against Medtronic over its SynchroMed Pump and Infusion System. According to the lawsuit, the Medtronic SynchroMed Pump and Infusion System received premarket approval (PMA) from the FDA in 1988. Medtronic’s SynchroMed EL Pump and Catheter received approval through a supplemental PMA in 1999. “The device is a system for infusing pain medication into the spine,” court documents indicated.
“Over the next few years, Medtronic became aware that a granuloma (a nodule of inflammatory cells) could form at the tip of the catheter, which had the potential to paralyze the patient,” the lawsuit indicated. “Medtronic did not report this problem to the FDA…. Meanwhile, in October 2000, in Tucson, Arizona” the man “had the Medtronic infusion pump and catheter system surgically implanted. The catheter was implanted inside the membrane surrounding his spinal cord. The pump delivered pain medication through the catheter tip directly to his spinal cord.”
The man suffered a fall in 2005 after experiencing decreased sensation in his right leg and urination issues. An initial consultation with a neurosurgeon did not diagnose the problem because the physician was not aware, according to court records, that the “Medtronic infusion pump could cause a granuloma to form at the catheter tip.”
The man was seen by a second physician a few days later. That physician noted, in a subsequent evaluation, that the man continued to experience “ascending paralysis in both legs.” The second consulting physician suspected the patient had a granuloma based on the physician’s prior experience with another patient. The doctor ordered tests, which confirmed a granuloma caused by the Medtronic pump catheter tip, which caused a complete blockage of the spinal fluid, “and compressed the spinal cord at the T12 level in his spine,” according to the lawsuit.
The patient underwent surgery to remove the catheter and the granuloma in his spine. The surgery was only partly successful, and “as a result of the granuloma caused by Medtronic’s device, [the plaintiff] is permanently paralyzed below the T12 level, in both legs,” according to the lawsuit.
Also, according to the lawsuit, “More than a year later, between November 2006 and January 2007, during inspections of a Medtronic manufacturing facility, the FDA discovered the problem caused by the infusion pump and catheter system and Medtronic’s extensive under-reporting of adverse events.” The lawsuit also alleged that Medtronic was aware—as early as 2001— concerning the potential of an inflammatory mass developing at the catheter tip.
Legal Help for Victims of Faulty Medtronic Medical Devices
Millions of people rely on Medtronic’s medical devices to help manage or resolve an array of health concerns. Unfortunately, they may have suffered serious injuries if the set they were depending on was part of the Medtronic Quick-set infusion set recall.
Our law firm is currently investigating potential lawsuits against Medtronic on behalf of people injured by Medtronic medical devices. To discuss your case with one of our Medtronic Recall lawyers, please fill out our online form or call 1-800 YOURLAWYER (1-800-968-7529) today.
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