SPRINT FIDELIS ICD LEADS

KEY POINTS

• Implantable cardioverter-defibrillators (ICDs) are implanted in high-risk patients who are at risk for life-threatening abnormal heart rhythms, particularly ventricular arrhythmias. Sprint Fidelis leads were approved to be used with ICDs in 2004. The “leads” are wires that attach to the heart and deliver therapy from the ICDs to restore normal heart rhythms. The Sprint Fidelis leads were developed to provide an alternative to Medtronic’s Quattro leads, which were the best-performing lead on the market. The Sprint Fidelis leads were designed to be smaller, easier to insert, and more flexible for patients.
• As a result of post-market monitoring, Medtronic determined that the Sprint Fidelis leads may be fracturing at a rate higher than expected. Medtronic advised physicians that it was monitoring the performance of the leads based on this early data. Several months later , based on its analysis of the projected performance of the lead and in consultation with an independent panel of physicians, Medtronic decided to voluntarily recall all Sprint Fidelis leads not yet implanted in patients. FDA agreed with Medtronic’s decision, and indicated that the leads continued to operate normally in the “vast proportion of patients.” The FDA, the independent physician panel, and Medtronic did not recommend the prophylactic removal of these leads, except in unusual individual patient circumstances.
• Medtronic continues to analyze and publish Sprint Fidelis lead performance data from multiple sources.

Overview

1. Ventricular Arrhythmias are Common and Serious Medical Conditions
   
   Ventricular arrhythmias are one of the most dangerous abnormal heart rhythms. They originate in the lower heart chambers, called ventricles. These types of arrhythmias can cause the heart to beat too fast (ventricular tachycardia) or chaotically (ventricular fibrillation). These arrhythmias can result in cardiac arrest and death.


2. Implantable Cardioverter Defibrillators (ICD)
   
   ICDs are used to prevent sudden death in patients who are at risk for cardiac arrest due to ventricular tachycardia or fibrillation. ICDs monitor the heart through sensors in the leads, and if they detect dangerous ventricular arrythmias, they deliver cardioversion or defibrillation therapy through high energy shocks or pacing therapy. ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest. All cardiac leads are subject to potential damage when operating inside the human body, depending on activity level, vasculature and other factors that may be patient-specific.


3. Sprint Fidelis Leads
   
   In 2004, Medtronic received premarket approval (PMA) for Sprint Fidelis leads after a six-month review by the FDA. As a result of its monitoring of the lead’s performance, Medtronic observed that Sprint Fidelis leads appeared to fracture at a rate higher than the Medtronic’s Quattro lead. Because this fracture rate was higher than expected, Medtronic advised physicians of its observations and that it was monitoring the performance data for further analysis. Several months later, in October of 2007, Medtronic voluntarily suspended distribution of Sprint Fidelis leads worldwide and voluntarily recalled all unimplanted leads based on its projections of expected future fracture rates.¹ Medtronic initiated this recall even though fracture rates were not statistically significant. At the time of the recall, approximately 268,000 Sprint Fidelis leads had been implanted, and the vast majority of Sprint Fidelis leads worked as designed beyond the five-year warranty period.


4. Safety and Continued Monitoring of Sprint Fidelis Leads
   
   FDA agreed with Medtronic’s decision to voluntarily stop distribution of the Sprint Fidelis leads, indicating that the leads were “slightly more prone to fracture” than predecessor leads. FDA also noted that the Sprint Fidelis leads “continue to function properly in the vast proportion of patients,” and FDA did not recommend prophylactic removal of Sprint Fidelis leads. Physicians were encouraged to monitor patients during their regularly scheduled follow-up visits for any indications of fracture.
   
   Since the recall, Medtronic and the Independent Physician Quality Panel have continued to analyze Sprint Fidelis lead performance data from the Medtronic Product Surveillance Registry, the Medtronic CareLink Network, and third party sources.²


5. Inaccurate and Misleading Media Claims Regarding Sprint Fidelis Adverse Event Reports
   Recent media stories suggest, based on “analyses” of “adverse event reports,” that Sprint Fidelis has been “linked” to numerous injuries and deaths. These stories are inaccurate and highly misleading. As the FDA has recognized, adverse events reports “cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices” and that “the number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.”¹
   
   That is because adverse event reports have significant and well-established limitations. As a threshold matter, the fact that an adverse event is reported regarding a certain device does not mean that the device malfunctioned or that the event is attributable to the device. Indeed, to be considered an “adverse event,” only the barest information is required. For medical devices, all that is needed is an allegation of an injury involving a device. Further, adverse event reports may be voluntarily filed by individuals with no medical training (e.g., patients, family members, or lawyers) and may contain limited or incomplete information. These reports also can be duplicative and occasionally affected by external factors such as media reports or litigation.
   
   Medtronic and the Independent Physician Quality Panel continue to analyze Sprint Fidelis lead performance data from the Medtronic Product Surveillance Registry, the Medtronic CareLink Network, and third party sources.² This data provides the most reliable data regarding the performance and safety of Sprint Fidelis leads.