Heart Rhythm Society Statement Regarding Medtronic’s Suspension of Distribution of Sprint Fidelis Defibrillation Leads
FOR IMMEDIATE RELEASE
Contact: Ann-Marie White
Heart Rhythm Society
202-464-3476
awhite@hrsonline.org
Washington, D.C. — Medtronic’s decision to voluntarily suspend its Sprint Fidelis defibrillation leads underscores the importance of the Heart Rhythm Society’s Task Force recommendations for the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (ICDs).
A 15-member task force of leading cardiac care providers and experts developed the guidelines with feedback from regulators at the FDA, representatives from industry and patient advocacy groups. Additional feedback was received from a public comment period that ended May 30, 2006.
“Our guidelines are intended to help ensure transparency and promote cooperation among manufacturers, physicians, patients and the FDA,” said Bruce D. Lindsay, M.D., FHRS, president of the Heart Rhythm Society. “Adhering to the principles of these guidelines can help ensure the best patient care possible.”
Released in September 2006, the overarching objectives of the HRS recommendations include the following:
- Greater transparency in the post-market surveillance, analysis and reporting of information;
- The establishment of new systems to identify malfunctioning devices more quickly;
- Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA and physicians are encouraged to work together to prevent adverse events due to device malfunctions; and
- The global scope of device performance issues; cooperation among industry, physicians, government authorities and national health care systems are necessary to reduce the risk of injuries and deaths due to device malfunctions.
Facts about ICDs:
- Studies of ICDs show they are 99 percent effective in detecting and stopping deadly heart rhythm disorders.
- In clinical trials, ICDs have been shown to be the most successful therapy to prevent sudden cardiac death in certain groups of high-risk patients.
Specific recommendations and more information are available in the Clinical Guidelines section of this website.
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About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of over 4,400 heart rhythm professionals in more than 67 countries around the world. For more information, visit www.HRSonline.org.
On October 15, 2007 the following letter was e-mailed to all Heart Rhythm Society members:
"You have likely seen today's media coverage around Medtronic's decision to suspend distribution of its Sprint Fidelis® defibrillation leads. This decision was made after five patient deaths occurred where a lead fracture may have been a contributing factor. While fracture rate is minimal, Medtronic is asking doctors to stop implanting the leads and return all unused leads to the company. In addition, Medtronic and the FDA are not recommending the routine surgical removal or replacement of functioning Sprint Fidelis leads (Models 6930, 6931, 6948, 6949) because of the associated risks of surgery or lead extraction.
"In response to this development, the Heart Rhythm Society has issued a statement acknowledging that the company's decision reflects an adherence to the guidelines issued by our 15-member Task Force in September 2006 on the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (ICDs). A number of links to relevant information regarding this issue, including the official HRS recommendations, are listed [here].
"Additionally, in consultation with Heart Rhythm Society staff and leadership, I have been speaking with members of the media about this issue to highlight the importance of the Society's recommendations and reiterate the safety of ICDs. We will be sure to keep you updated on this issue through member communications and the Heart Rhythm Society homepage.
Sincerely,
Bruce D. Lindsay, MD, FHRS
President, Heart Rhythm Society
