[Transmitted via e-mail October 15, 2007]
Dear HRS Member,
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 below.
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
