Recalled Medtronic Leads More Likely to Fracture in Children
November 23rd, 2007 amy
Back on October 19, the Wall Street Journal article “Heart Wires May Pose More Risk for the Young” reported that the recalled Medtronic defibrillator leads had a higher rate of fracturing in children, for whom the leads were thought to be a practical solution since the thinner leads were better fits for smaller bodies. The research findings of Wayne H. Franklin, MD, a Northwestern University pediatric cardiologist, were the heart of the story, noting that Medtronic reported far fewer fractures in children than Dr. Franklin’s study revealed.
Per the WSJ, “Medtronic has reported a lower failure rate, 2.3% after 30 months, for all patients implanted with one particular Sprint Fidelis model. For that same model, Dr. Franklin saw a fracture rate of 4.9% among 304 patients in his survey.” The WSJ article sparked some controversy among medical professionals who felt the story was sensationalized and didn’t account for the fact that all defibrillator leads are more likely to fracture in children or active young adults.
The truly disturbing information comes from what wasn’t reported.
Dr. Franklin comments on the weblog
(http://drwes.blogspot.com/2007/10/kick-em-when-theyre-down.html) of Westby G. Fisher, MD, another cardiologist at Evanston Northwestern Healthcare, that “The Prospective analysis only evaluated 6949 leads and DID NOT INCLUDE ANY PEDIATRIC INSTITUTIONS!!!”
Franklin further posts, “At our request, Medtronic did an analysis of their data for survival of the Fidelis leads of patients below age 21 compared to the Quattro based on their RPA (by their admission, an UNDERESTIMATE of the true rate). The 6949 lead had a survival rate of 96.2% while the Quattro had a survival rate of 99.4%. Again, this is survival rate, not fracture rate. Their data are consistent with ours.
The 95% CI for our data for fracture in all leads was 3.86-7.83%.
Medtronic realizes that they have a larger problem with these leads in younger people.”
So, Medtronic markets its defibrillators to doctors as a smart choice for implanting in children but neglects to take into account that its defective leads have the potential to kill more kids than adults, even after the recall, until prompted to research the matter by a prominent cardiologist whose study Medtronic had to know would go public. Nice.
