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Many are not aware that several people suffer from arrhythmia or irregular heartbeats. What’s unfortunate about this condition is that patients usually do not experience any symptoms that foretell if a life-threatening episode is about to occur.
When they do have symptoms present, these could either be palpitations, feeling a pause in between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain.
While most arrhythmias are not serious, they could still lead to life-threatening adverse complications such as stroke, heart, failure, cardiac arrest, or death.
A way to manage arrhythmias in patients who are at high risk of life-threatening attacks is through defibrillation, which delivers doses of electrical shocks to patients to restore their heartbeats to a normal pace. Defibrillators could be external, transvenous, or implanted – typically depending on the needs of the patient and the type of device that is used.
Sprint Fidelis Leads (SFLs) are specific models of defibrillators that have cardiac electrodes or thin wires that connect to an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that aim to protect patients when life-threatening arrhythmias occur.
First approved by the United States Food and Drug Administration in 2004, the Medtronic Sprint Fidelis was intended to replace an older model that had thicker leads called the Sprint Quattro, which was approved by the same agency in 2001.
Reports eventually surfaced regarding malfunctions with the leads of the Medtronic Sprint Fidelis. The electrodes, or leads, were found to likely fracture or break.
When these wires break, it could: (1) inaccurately read the heartbeat rhythm, alerting the patient that it requires immediate medical attention, (2) deliver an electrical shock when not necessary, potentially causing injury or death to the patient, or (3) fail to send an electrical shock when life-threatening heart rhythms occur.
Medtronic Sprint Fidelis
According to the United States Food and Drug Administration:
“Manufactured by Medtronic Inc., Sprint Fidelis Leads (SFLs) are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.”
Defibrillators, like that of Medtronic’s product, work by monitoring heart rhythms. These devices deliver electrical shocks or rapid pacing for the heartbeats to return to its normal rhythm when life-threatening arrhythmias are detected. This type of medical device prevents heartbeats from going too fast, and is surgically implanted in patients at risk for spontaneous cardiac arrests.
Medtronic first introduced the medical device in 2004, after receiving approval from the United States Food and Drug Administration to replace an older model called Sprint Quattro – approved in 2001, which is known to have thicker leads or electrodes.
In October 2007, Medtronic made an announcement regarding several SFLs found to have faulty electrodes, which are the conductors of the electric shock delivered to the heart.
It was found that the wires could fracture or break, which could result in either sending shocks during unnecessary instances, or failing to deliver shocks when they are needed.
Even though the SFLs were recalled, the action does not affect patients who have pacemakers manufactured by the same company, because pacemakers are designed to keep the heart from beating too slowly.
Furthermore, the faulty products do not affect patients who have Medtronic-branded ICDs or CRT-Ds without an SFL.
People who suffer from sudden episodes of arrhythmia, more commonly known as irregular heartbeats, typically do not experience symptoms to detect if an episode is on the way.
However, if there are symptoms present, they could be palpitations or feeling a pause in between heartbeats. Other symptoms include lightheadedness, passing out, shortness of breath, or chest pain. Most arrhythmias are not serious, but they could lead to adverse complications like stroke, cardiac arrest, or heart failure.
One way for patients to manage this condition is through defibrillation, which consists of delivering doses of electrical energy to the heart with the use of a defibrillator. These can either be external, transvenous, or implanted, depending on the type of device used or necessary for the patient.
Defibrillator Lead Malfunctions
There are three major malfunctions that could happen as a result of the defective electrodes on the Medtronic defibrillator product:
- The defibrillator could beep, thereby alerting that the patient has a problem that requires urgent medical attention
- A massive electrical shock could be delivered when not needed, which could be fatal in some patient cases
- The battery could drain, causing the device to fail or not deliver shocks when needed
There are currently no reliable tests that could tell if the lead of the products will fracture in the future. However, even with the presence of risk of malfunctions, experts do not recommend that the recalled products be surgically removed.
The only solution Medtronic could suggest was to urge patients who might have the SFL implanted to have their doctors reprogram the defibrillator to better monitor for lead problems. This increases the probability that the device would detect a fracture before its malfunctions cause any harm to patients.
However, this still does not provide any assurance to patients who have a defective SFL implanted. Patients are still faced with the high rate of adverse risks associated with implanting a second lead or replacing the existing lead.
Lawsuits and Litigation
On December 2007, an investor in the company filed a lawsuit against Medtronic in the U.S. District Court of Minneapolis, where the device maker is headquartered. The suit pursued class action certification on behalf of all the Medtronic investors who invested in the company’s stock from June 25, 2007 to October 15, 2007, the same day the company announced its recall.
The complaint charged the company and particular directors with violating the Securities Exchange Act of 1934. The plaintiff was seeking for compensation on damages in behalf of all the involved class members.
Furthermore, the lawsuit alleged the device maker of “many false and misleading statements” regarding the SFLs, all while knowing that the electrodes were defective and malfunctioning.
“As of November 26, 2008, approximately 930 lawsuits regarding the Fidelis leads have been filed against the Company, including approximately 36 putative class action suits reflecting a total of approximately 1,450 individual personal injury cases. In general, the suits allege claims of product liability, warranty, negligence, unjust enrichment, emotional distress and consumer protection violations. One lawsuit includes a claim by an individual purporting to act as a surrogate for the Center for Medicare and Medicaid Services, and one lawsuit has been brought by a third party payor as a putative class action suit. In addition, one putative class action has been filed in the Ontario Superior Court of Justice in Canada. Approximately 255 of the lawsuits have been filed in state court, generally alleging similar causes of action. Of those state court actions, approximately 235 are consolidated before a single judge in Hennepin County District Court in the state of Minnesota. The federal court cases have been consolidated for pretrial proceedings before a single federal judge in the U.S. District Court for the District of Minnesota pursuant to the MDL rules. The MDL court has entered and Order staying all discovery pending the outcome of a December 17, 2008 hearing on Medtronic’s motion to dismiss the complaints. The Company has not recorded an expense related to damages in connection with the matter because any potential loss is not currently probable or reasonably estimable under SFAS No. 5.”
In October 2010, Medtronic announced that they have entered into a settlement agreement with lawsuits regarding their SFLs. All lawsuits and claims pending as of October 15, 2010 – approximately 8,100 lawsuits — were given an overall payment of $268 million, including attorney fees and administrative expenses. This comes out to a measly $33,000 per plaintiff.
According to the press release:
“The parties will file joint requests to terminate the Multi-District Litigation (MDL) and Minnesota state court proceedings related to the Sprint Fidelis leads and to dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals. The parties will also request dismissal of other Fidelis-related cases throughout the country. Medtronic can cancel the agreement if certain conditions are not met, and the agreement can be terminated by either party if the MDL proceedings are not terminated.
The cases in the settlement are those arising in the United States from the October 15, 2007 Sprint Fidelis field action, including cases currently filed either in the MDL or in state courts. All settling plaintiffs must satisfy any insurance claims and subrogation interests of Medicare or Medicaid from their settlement payments. No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys’ fees.”
The settlement agreement also stipulates that Medtronic denies any liability or any validity with regard to the allegations stated in the lawsuits.
FDA Recalls, Reports and Warnings
It was in March of 2007 when Medtronic issued an advisory to doctors stating that its medical device “had a higher than expected failure rate” and that the issue was undergoing investigation.
While the investigation was still in the works, the product was still being marketed and sold in the market, and the company failed to add or reinforce warnings associated with the implantation of the device.
In October 2007, Medtronic announced that there was a defect in the SFL component of its heart defibrillator. The company stated that they discovered a possibly high rate of fracture in the electrical wires of the medical device, which can ultimately alter the accuracy of heart rhythm readings.
In addition, the defect can result in misfires and shocks in the patients, or it could also fail to provide a life-saving shock onto the patient.
According to FDA reports, an estimated 268,000 patients were implanted with an SFL as part of a Medtronic defibrillator since 2007. Sprint Fidelis models affected are: (1) Model 6930, (2) Model 6931, (3) Model 6948, and (4) Model 6949.
Patients who have obtained the Medtronic defibrillator beginning 2004 were urged to visit their corresponding doctors to check for any potential fractures.
The New York Times also reported that the defects found in the electrical wires led to hundreds of malfunctions, claiming that it could have possibly caused the death of five patients who used the device.
Along with the announcement, the device maker also recommended that doctors stop using SFLs in patients who are using its defibrillators. Medtronic also suspended international distribution of the product and recalled all the leads that were not in use; the recalls were also endorsed by the FDA as a Class 1 recall (the defect has a high potentially of leading to serious injury or death).
Following the cease in distribution of the product, lawsuits from both investors and patients increased. However, a Supreme Court decision ruled that the company could not be held liable for the device, which met the highest regulatory standards of the FDA.
In 2009, the company told doctors and physicians that the leads failures might have been a significant factor into the deaths of at least 13 patients who obtained the device.
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