While there is probably no larger cardiac device concern for electrophysiologists and their affected patients, Medtronic's disclosure with patient management recommendations based on Hauser's data and others before the release of the upcoming article in the New York Times is appreciated and should assist patients and doctors as they discuss their treatment options. Importantly, Medtronic points out:
"The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty. The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.So we'll see that the news article says, but one thing's for sure...
The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed."
...Monday should be interesting.
NYT article 13 Mar 2009: "Medtronic Links Device for Heart to 13 Deaths"
Dr. Wes: Medtronic's Sprint Fidelis Performance Lead Update - May 13, 2008
Dr. Wes: Challenges With a Lead Recall - Oct 17, 2007
Dr. Wes: More on Medtronics Sprint Fidelis Advisory - Oct 15, 2007