>>FDA LINK (7/13/2009): Medtronic Paradigm Quick-Set Infusion Set Recall

Late in the day Friday, Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.

The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.

Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.

MEDTRONIC INSULIN PUMP LAWYERS

Individuals have been told to stop using “Lot 8” Quick-set infusion sets and Medtronic is offering to exchange all affected products at no charge. However, for individuals who have been hospitalized or suffered severe injuries as a result of incorrect delivery of insulin from their pump, the recalled units should be saved until after it is determined whether financial compensation may be available through a Medtronic insulin pump lawsuit.

If you, a friend or family member experienced Medtronic insulin pump problems after using any of the recalled Quick-set infusion sets, request a free consultation and claim evaluation.

Medtronic issued a warning to doctors after receiving reports of at least two patient deaths.

Approximately 2% of all Medtronic Kappa 600, 7000 and 900 series pacemakers and Medtronic Sigma 100, 200 and 300 series pacemakers could be defective and experience a problem with the internal circuitry.

Wires that connect the electronic circuit to other components in the pacemaker, such as the battery or connector, could separate resulting in potential loss of rate response, premature battery failure, loss of telemetry or no output. This could cause return of bradycardia symptoms or potentially result in death or serious injury.

Medtronic has notified doctors that there is no testing that can predict whether one of their pacemakers may fail and no device re-programming can reduce the risk.

Symptoms of lightheadedness or fainting could be potential signs of a Medtronic pacemaker malfunction, and patients have been urged to seek immediate medical attention if they experience any problems.

The Medtronic Sigma and Kappa pacemakers were primarily manufactured between November 2000 and November 2002 and have an estimated average remaining life of between 1.2 years and 3.8 years depending on the model.

MEDTRONIC PACEMAKER LAWSUIT

Registered patients with the potentially defective Medtronic pacemakers will be notified by letter dated May 27, 2009. To determine if a specific serial number for a Sigma or Kappa pacemaker is impacted by these problems visit KappaSigmaSNList.medtronic.com.

If you, a friend or family member have one of the potentially defective pacemakers, contact our lawyers to request a free consultation and claim evaluation.

>>Contact Your Senators
>>Contact Your Representative

The Medical Device Safety Act of 2009 was introduced in the U.S. House and U.S. Senate to reverse a decision by the U.S. Supreme Court last year in Riegel v. Medtronic, which held that product liability lawsuits challenging the safety or effectiveness of medical devices are pre-empted by federal law if they are approved by the FDA.

Corporations which manufacture defective medical devices and dangerous drugs have been arguing for years that they should be insulated from liability for injuries caused by their products so long as the FDA approved the products. However, in reality, the FDA is not equipped to be the last line of defense for product safety, and their regulations should be viewed as the floor, not the ceiling.

Ultimately, responsibility for the safety of medical devices and prescription drugs should fall to the manufacturer, and a consumer should be entitled to compensation when a corporation fails to ensure that their product is safe and effective.

Earlier this month, in the case of Wyeth v. Levine, the U.S. Supreme Court came down on the side of the consumer, finding that makers of pharmaceutical drugs are not insulated from liability for faulty warning labels, regardless of whether the FDA approved the label.

However, the Riegel decision is continuing to present substantial hurdles for individuals injured by defective medical devices, such as the Medtronic Sprint Fidelis defibrillator lead that was recalled in 2007.

Although Medtronic was aware that the small wires they were selling to connect cardiac defibrillators to the heart were prone to fracture or break, they continued to allow the products to be implanted for months.

In January 2009, U.S. District Judge Richard H. Kyle in Minneapolis cited the Riegel decision as the basis of his dismissal of over 1,400 Medtronic lawsuits that had been filed on behalf of patients who were injured by the defective Medtronic defibrillator leads.

The legislation introduced by Sentator Edward Kennedy (MA-D), Rep. Frank Pallone (NJ-D) and House Energy and Commerce Chairman Henry Waxman (CA-D) could restore these lawsuits and protect other consumers injured by medical devices, by ensuring that they are able to hold the manufacturer responsible for a negligent design that results in a dangerous and defective medical device.

ACT NOW TO SUPPORT THE MEDICAL DEVICE SAFETY ACT

To preserve your right to pursue a product liability lawsuit for injuries caused by a bad medical device, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act.

The civil justice system and state court juries are an important safeguard to hold companies accountable for decisions which put profits ahead of consumer safety. Let your voice be heard.

>>Read More from American Association for Justice.

The class action lawsuit stems from recent reports of an investigation by the Justice Department that suggest Medtronic was actively marketing and promoting their bone stimulator for use in the cervical spine and other unapproved uses, which have been associated with a high rate of complications, such as compression of the airway or nerves, and possible death.

The Medtronic Infuse Bone Graft is only approved for use in the lumber spine and for certain dental procedures. It is designed to avoid the need to harvest bone from the hip, using a liquid bone stimulator, known as human bone morphogenetic protein, or BMP, to encourage bone growth and help replace spinal disks that are damaged.

Due to the close proximity between the cervical spine and the airway, use of the Medtronic bone graft during neck fusions could cause problems like:

• Difficulty Breathing
• Difficulty Swallowing
• Difficulty Speaking
• Nerve Damage
• Death

The Medtronic Infuse Bone Graft class action lawsuit was filed on behalf of investors who were shareholders of Medtronic, Inc. between November 19, 2007 and November 17, 2008, alleging that the company concealed and failed to disclose the extent of their Infuse Bone Graft problems and the degree to which their revenue for the flagship product was reliant on “off-label” use and their illegal promotion.

MEDTRONIC INFUSE BONE GRAFT LAWSUITS

For cervical fusion or neck surgery patients who have been injured as a result of the off-label use, the Medtronic Infuse Bone Graft lawyers at Saiontz & Kirk, P.A. are investigating and reviewing the potential for lawsuits on behalf of individuals throughout the United States. If you, a friend or family member have experienced problems, request a free consultation and claim evaluation.

>>REVIEW A MEDTRONIC INFUSE LAWSUIT WITH A LAWYER<<

The Medtronic Infuse bone graft is a man-made liquid bone stimulator that is used to promote bone growth and replace damaged spinal disks by filling in the gaps between vertebrae. Although it has only been approved by the FDA for use in the lumbar spine and during certain dental bone grafting procedures, the bone stimulator has been widely used “off-label” in the cervical spine or neck.

Use of the Infuse bone graft in the cervical spine has been associated with the potential development of severe neck swelling, which may compress the airway and the nerves. This could cause problems to develop within days or weeks of surgery, including difficulty breathing, trouble swallowing, inability to speak, respiratory arrest or even death.

Medtronic currently faces a criminal investigation by the U.S. Department of Justice involving their promotion and marketing of the Infuse bone stimulator for use in the cervical spine. Although they have never established that it is safe and effective when used in the cervical spine, Medtronic placed profits before patient safety to increase sales of the device.

According to the Wall Street Journal, what is believed to be the first Medtronic Infuse bone graft lawsuit has recently been filed in California involving the use of this device in the cervical spine. The lawsuit alleges that Medtronic encouraged the Plaintiffs’ doctors to use the Infuse bone graft in the cervical spine, and that representatives from Medtronic were even present during the surgery.

The Medtronic Infuse bone graft lawyers at Saiontz & Kirk, P.A. suspect that this situation is not unique, as many other individuals throughout the United States have experienced cervical fusion surgery complications caused by use of the Medtronic bone stimulator.

If you, a friend or family member have experienced compliations or problems following use of the Medtronic Infuse bone graft in the cervical spine or neck, contact our attorneys to evaluate whether compensation may be available. To review a potential case, request a free consultation and claim evaluation.

>>INFORMATION: Medtronic Lead Recall

The Medtronic recall was issued because the Sprint Fidelis lead was found to have an increased risk of fractures or breaks, which could result in unnecessary shocks or cause their defibrillator not to work if it is needed to provide life-saving treatment.

Given the considerable risk involved in attempting to remove a Medtronic defibrillator lead or implant a new lead, experts have recommended that the leads not be extracted unless there is evidence of a fracture. At the time of the recall, doctors were told to reprogram their patient’s ICDs so that they could better detect when something went wrong, and patients were reassured that this would minimize the risk of injury or harm if the lead fractures.

However, a study published in February 2008 on a website for the Heart Rhythm Society, indicated the enhanced monitoring was relatively ineffective in preventing Medtronic lead problems and adverse health events. Of 514 Sprint Fidelis leads implanted at the Minneapolis Heart Institute, data indicated that 17 failed between 11 and 35 months after insertion. Although the defibrillators had been reprogrammed, researchers found that 12 of these patients received inappropriate shocks and two did not hear the warning alarms.

The latest software update is designed to help doctors improve their chances of identifying a potential fracture earlier. However, it still will not help reduce the risk of a fracture, and it will not help doctors repair a fracture if one does develop.

Even if the software does allow doctors to better detect the fracture before the patient experiences an unnecessary shock or failure of their defibrillator, they will still face a risky procedure to attempt to extract the lead or implant a new one. These procedures carry a risk of infection, damage to the heart valve, the possibility that the lead may puncture or perforate the heart or damage the vein.

MEDTRONIC LEAD RECALL LAWSUITS

It has been nearly a year since the Medtronic defibrillator lead recall was issued for the Sprint Fidelis wires. Thousands of people have been living in fear that their leads may fracture and they have been receiving additional medical monitoring to watch for signs of a fracture. These problems could have been avoided if Medtronic had done a better job of designing, manufacturing and testing their product.

The Medtronic lead lawyers at Saiontz & Kirk, P.A. represent individuals who received the Sprint Fidelis lead, regardless of whether they have yet to experience Medtronic lead problems. A number of legal hurdles are being faced, but our lawyers remain committed to pursuing all of the legal options available to our clients.

Potential Medtronic lead recall lawsuits are still being reviewed for individuals who do not have legal representation. If you, a friend or family member received a Medtronic Sprint Fidelis lead to connect your cardiac defibrillator to the heart, request a free consultation and claim evaluation.

>>INFORMATION: Medtronic Defibrillator Lead Recall

The information provided to physicians who treat those with cardiac defibrillators indicates that Medtronic’s continued analysis of data has found that the probability of a Sprint Fidelis lead fracture through 30 months is 2.5%, which is only minimally more than the original estimate of 2.3%. Although the risk remains small, given the number of leads which have been implanted, 5,000 people could expect their lead to fracture within the first two and a half years.

>>LINKS: Medtronic Patient Letter
Medtronic Physician Letter

As more leads reach 33, 36 and 39 months post-implant, additional information will be available to provide a better understanding of the lead’s performance. In the meantime, the only reassurances provided to patients are Medtronic’s patient management recommendations, which are designed to provide advance notice of a lead failure. However, the letter indicates that more than half of the fractures detected will be found with less than two days before the therapy fails or with no notice at all.

Westby G. Fisher, M.D., an independent internist, cardiologist and cardiac electrophysiologist who contributes to a blog as “Dr. Wes”, discussed the Medtronic letter he received in a recent post on May 13, 2008:

By Medtronic’s analysis of a typical 1000-patient ICD clinic, over the next 12 months, nine (9) patients can be expected to have an anode or cathode failure and half of those patients will have little warning of an impending fracture.

The implications of these recommendations are far-reaching, for it now seems the fault with the lead was not a physician implant technique problem as originally surmised, but rather a design flaw. Further, when it comes to replacing these patient’s defibrillator batteries over the next four or five years, electrophysiologists will likely be advised to replace the 6949 lead (Medtronic Sprint Fidelis) with a more reliable defibrillator lead model, like the 6947 (Medtronic Sprint Quattro Secure), increasing the difficulty of a typical device battery change procedure.

MEDTRONIC LEAD RECALL ATTORNEYS

The attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who had a Medtronic Sprint Fidelis Lead (Models 6949, 6948, 6931, 6930) implanted to connect their defibrillator to the heart. Although nearly all people who had one of the leads implanted have been notified about the recall and are continuing to follow up with their physicians, many still have not consulted with an attorney to review their legal rights. To speak with an attorney and review a potential case, request a free consultation and claim evaluation.

>>INFORMATION: Medtronic Defibrillator Wire Lawsuits

On October 15, 2007, a Medtronic recall was issued for all models of the Sprint Fidelis lead (model numbers with 6930, 6931, 6948 or 6949). The small defibrillator wires were found to be prone to fractures or breaks, which could cause the defibrillator to malfunction by delivering inadvertent shocks or failing to provide necessary treatment if the heart becomes unstable.

Letters have been sent to most individuals who have one of the recalled Medtronics defibrillator wires implanted. Despite the potential risk of failure, individuals are often unable to have the defective defibrillator wire removed, since the risks associated with such a procedure can be even higher than the risk associated with leaving the lead in place.

According to Medtronics initial estimates, the Sprint Fidelis defibrillator wires have a 2.3% failure rate at 30 months after they are implanted. Given the 235,000 leads implanted, these conservative estimates indicate that over 5,000 people could suffer a wire fracture. However, many experts expect that number to be substantially higher as follow up data is reviewed in future years.

Defibrillator leads are considered a permanent device, and even if the actual defibrillator is replaced, any new device is usually connected to the existing leads. The defibrillator wires are inserted into the veins leading to the heart and it is risky to try to remove them after scar tissue forms around the lead. The longer they remain in place, the more the thin electrical wires are exposed to the stress and strains associated with body movements, potentially increasing the risk of a defibrillator malfunction in future years.

Even if an individual’s Medtronic Sprint Fidelis lead does not currently have any signs of failure, they still have legal rights which must be protected. All individuals who have one of the recalled Medtronic defibrillator wires face a lifetime of emotional distress over the risk of potential problems, possible limitations on their ability to participate in certain activities and medical expenses associated with increased monitoring for potential problems.

MEDTRONIC DEFIBRILLATOR WIRE LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential Medtronic defibrillator wire lawsuits throughout the United States. If you, a friend or family member have had a cardiac defibrillator implanted since 2004, one of the defective defibrillator leads could have been used. To determine if you, a friend or family member may be eligible for financial compensation, request a free consultation and claim evaluation.

>>INFORMATION: 2007 Medtronic recall

The Medtronics Sprint Fidelis lead is a small electrical wire used with implantable cardiac defibrillators, also known as ICD or CRT-D. The wire connects to the heart muscle to monitor the beat and deliver a life saving electrical charge if an abnormal heart rhythm is detected.

When it was introduced in September 2004, the Sprint Fidelis lead was the smallest defibrillator wire available, replacing the Sprint Quattro which was introduced in 2001. Medtornic, Inc. is a global leader in heart devices and they heavily promoted the thin wire to gain a competitive advantage over other cardiac device companies. As a result, many doctors elected to use the Sprint Fidelis lead.

While the smaller lead does make for easier insertion, there are no established long term benefits of a smaller wire. After the Sprint Fidelis lead was placed on the market, Medtronic received reports of defibrillator problems where individuals suffered unnecessary shocks or the device failed to properly function when it was needed to deliver a life-saving treatment. Despite evidence of problems with their lead, they delayed issuing the recall, exposing thousands to an unnecessary risk.

>>PRIOR POST (11/1/2007): Medtronic recall could have come earlier

In the wake of this recall, many have questioned the widespread use of defibrillators in the United States and whether the devices were the best treatment option for many who have one of Medtronics leads. While the devices are credited with saving lives every year, some doctors choose to treat patients with medications instead of an implanted defibrillator. Data has suggested that as many as 80% of the individuals who receive a defibrillator never need the life-saving electrical charge.

Sales of the heart devices to Americans in 2006 accounted for more than $4 billion of the $5.6 billion global market for defibrillators. This was partially due to heavy marketing campaigns designed to convince doctors that their patients should be referred for one of the devices. Medtronic even ran a brief advertising campaign which was directed to patients, as opposed to doctors.

MEDTRONIC DEFIBRILLATOR LEAD RECALL LAWYERS

The lawyers at Saiontz & Kirk, P.A. represent individuals who have had one of the Sprint Fidelis defibrillator leads implanted (model numbers 6930, 6931, 6948, 6949). Medtronic recall lawsuits are being reviewed regardless of whether defibrillator problems have been caused by the defective leads. If you, a friend or family member believe you may have one of these leads, request a free consultation.

The Medtronic settlement will provide financial compensation to individuals who were impacted by defects in some models of the Marquis implantable cardioverter defibrillator (ICD). The defibrillator recall was issued in February 2005 as a result of battery problems which could cause the device to fail. Over 10,000 people had to have their defibrillator surgically removed as a result of the recall.

According to the Medtronic defibrillator lawsuits, the company was aware of the battery problems well before they issued the recall. As a result of their desire to maximize profits and sell their stock of defibrillators, they allowed defective devices to be implanted in patients and failed to warn that safer defibrillators were available.

Implantable cardioverter defibrillators, or ICDs, are small devices about the size of a stopwatch which are implanted near the shoulder and connected to the patient’s heart by a small electrical wire which runs through the vein. The device is designed to monitor the heart’s rhythm and deliver a life-saving shock if a rapid beat is detected. They are often implanted when an individual is at risk for sudden cardiac death.

Additional Medtronic lawsuits are being pursued as a result of an October 15, 2007 recall involving defects in the leads, or small wires, which carry the electrical charge to the heart. Medtonic Sprint Fidelis models of defibrillator leads are prone to fractures, which could cause the device to fail or result in unnecessary shocks. According to preliminary estimates released by Medtronic, the defibrillator leads have a failure rate of around 2.3% at 30 months, which means that approximately 4,000 to 5,000 will experience problems with their defibrillator.

Unfortunately, the process of replacing the defibrillator lead or attempting to insert a new wire is much more complex and dangerous than replacing the actual defibrillator. Experts are not recommending that the defibrillator leads be replaced unless there is evidence of a fracture. However, individuals who have one of the defective Sprint Fidelis leads will likely still be entitled to financial compensation from Medtronic, even if they never experience problems with their lead.

MEDTRONIC RECALL LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who are pursuing Medtronic lawsuits as a result of defective defibrillators and leads. New cases are being reviewed as a result of the defibrillator lead recall for any individuals who have one of the defective wires implanted with their defibrillator. If you, a friend or family member have received a defibrillator since 2004, it is possible the Sprint Fidelis lead was used. To find out if financial compensation may be available, request a free claim evaluation.

>>MORE INFORMATION: Medtronic lead recall

FDA PATIENT SAFETY NEWS: MEDTRONIC LEAD RECALL VIDEO

The monthly broadcast of the FDA Patient Safety News show contains updates and information about FDA safety notifications and product recalls, as well as information about ways patients can protect themselves when using medical products.

On October 15, 2007, the FDA and Medtronics, Inc. issued a nationwide recall for the Sprint Fidelis Cardiac Defibrillator lead.  The small electrical wires are prone to fracture or break, which could cause unnecessary shock or device failure.

According to initial estimates, approximately 2.3% of all leads implanted suffered problems within 30 months.  This could mean that between 4,000 and 5,000 people could experience problems. 

MEDTRONIC LEAD RECALL LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are investigating potential Medtronic lead recall lawsuits for any individuals who had one of the recalled leads implanted with their defibrillator, even if no problems have been experienced.  Consult with your physician or review you patient information card to determine if you, a friend or family member may have one the recalled leads.

Free consultations and claim evaluations are available to help determine if one of the recalled defibrillator leads were used .  There are no fees or expenses unless a recovery is obtained.  To determine if financial compensation may be available, request a free consultation.

It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).

On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead.  Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure. 

A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004.  In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.

Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company.  Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture. 

>>PRIOR POST 10/24/2007: Congress investigates Medtronic recall

A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania.  The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States.  The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.

MEDTRONIC DEFIBRILLATOR LEAD LAWSUITS

Approximately 235,000 people have one of the recently recalled Sprint Fidelis leads, and many of these individuals are pursuing lawsuits to seek substantial compensation from Medtronic for what they have been put through.  The lawyers at Saiontz & Kirk, P.A. represent individuals who are filing Medtronic lawsuits nationwide. 

Any defibrillators implanted since 2004 could have the Sprint Fidelis lead.  To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.

>>INFORMATION: Medtronic Defibrillator Wire Recall

After the October 15, 2007 recall, Medtronic began sending letters out to individuals who received one of their Sprint Fidelis defibrillator wires.  The company attempted to reassure their customers by stressing the low overall fracture rate and indicating doctors can reprogram the defibrillator to help discover a fracture before the defibrillator fails.  The device can be set to test for abnormalities in resistance of the lead or other electrical functions which could be signs or signals of a potential Medtronic lead failure.

Unfortunately, even if close medical monitoring discovers a possible fracture before the defibrillator fails, this may not reduce the risk of serious injury or death.  Early discovery could prevent unnecessary electrical jolts or failure of the device, but individuals will still face risks associated with attempting to replace the Medtronic wire, run a new lead or disable the defibrillator.

Attempting to replace defibrillator wires once they have been in place for a period of time is a very risk procedure.  Scar tissue forms around the wire, which could result in torn veins or damage to the heart muscle if an attempt is made to remove the defibrillator lead.  It is also risky to attempt to place a new lead in the vein to connect the defibrillator to the heart, and disabling the device is not a viable option for individuals who were given the defibrillator because they are at risk for sudden cardiac death.

MEDTRONIC DEFIBRILLATOR WIRE LAWSUITS

The lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have had one of the Sprint Fidelis leads implanted.  Even if evidence of a fracture has not been detected, individuals may be entitled to compensation through a Medtronic law suit.  To determine if you, a friend or family member may qualify for a claim, request a free consultation and case evaluation.

>>INFORMATION: Medtronic wire recall

On October 15, 2007, Medtronics announced that they were removing their Sprint Fidelis defibrillator lead from the market.  The wire was recalled as a result of a design defect which could allow the lead to break or erode.  While all individuals who were given one of the Sprint Fidelis leads could be at risk of serious and life threatening injuries, younger individuals or those who are more active could have an increased failure rate due to fractures caused by flexing and bending of the wire.

At the time the Medtronic wire recall was announced, the company estimated that their leads had fractured at a rate of 2.3% at 30 months.  During the conference call yesterday afternoon, the company declined to update any estimates of the failure rate.  Based on the initial estimates, between 4,000 and 5,000 people will experience a lead failure.  However, many experts believe that as more people have the leads for longer periods of time, the failure rate could increase drastically, impacting thousands more.

Medtronic, Inc. is the largest manufacturer of heart-rhythm devices in the world.  It generates over $12.3 billion in annual sales, and their division which includes defibrillator related sales account for about 40%.  Executives estimated that Medtronics defibrillator business experienced a 16% drop in sales during their most recent quarter, despite the fact that the Sprint Fidelis recall only impacted the last two weeks of the 13 week period.

The Sprint Fidelis wire was introduced in September 2004 as the thinnest defibrillator lead available.  Although it was used with most Medtronic defibrillators sold since then, it was also be used with other defibrillators manufactured by St. Jude, Guidant or Boston Scientific, as the doctors can mix and match the leads and defibrillators.  Since the Medtronic lead recall, many doctors have turned to other leads manufactured by different companies, instead of reverting to the older Medtronic Sprint Quattro lead.

MEDTRONIC RECALL LAWSUITS

Medtronic wire recall lawsuits are being pursued by thousands of individuals who had one of the defective Sprint Fidelis leads implanted with their defibrillator.  During the quarterly conference call with investors, the company indicated  that it was too soon to estimate the financial impact the Sprint Fidelis lawsuits will have on the company.

The lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have received a Sprint Fidelis lead.  The Medtronic wire lawsuits are being pursued to obtain compensation for the physical and emotional injuries caused by the manufacturer’s negligence in providing a dangerous and defective device.  To obtain a claim evaluation, request a  free consultation with our Medtronic lawyers.