This Medtronic Defibrillator Lead Line Was Particularly Popular In Younger Patients Due To Its Smaller Size
(Posted by Tom Lamb at DrugInjuryWatch.com)
In an October 19, 2007 article, "Heart Wires May Pose More Risk for the Young", Wall Street Journal (WSJ) reporters Anna Wilde Mathews and Thomas M. Burton continued to develop the evolving story about the Medtronic Sprint Fidelis recall. This latest news report concerns children and younger adults who have defibrillators with Sprint Fidelis leads.
Here is what we learned from this WSJ article about pediatric patients and why their risk of experiencing a defibrillator malfunction is higher than older patients:
[Medtronic Inc.] said that of the 268,000 Sprint Fidelis leads implanted, 2,085 were in patients under the age of 21....
Preliminary data from physicians at 32 institutions who specialize in treating pediatric patients and adults with congenital heart disease showed a fracture rate of 6.7% among 569 patients with Sprint Fidelis leads over 30 months. The "vast majority" of the patients are likely to be under the age of 21, given the physicians involved, says Wayne H. Franklin, an associate professor at Northwestern University's Feinberg School of Medicine, who gathered the physician reports.
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 real difference may be slightly greater, because the failure rate from Medtronic includes more than just fractures.
These WSJ reporters point out in their October 19 article that all defibrillator lead wires, not just the Sprint Fidelis line by Medtronic, have higher fracture rates in children and young adults because the leads are subjected generally to a higher level of stress for two reasons: children's hearts beat more quickly than older adults; and, these younger patients tend to be a more physically active.
Returning to this October 19 WSJ article about Medtronic's Sprint Fidelis defibrillator leads:
Dr. Franklin's data add to those released Monday by Medtronic. The company said that in patients younger than 21, the failure rate of one Sprint Fidelis model after 30 months was higher than that for all patients: 3.8% compared with 0.8%. That finding was based only on data gathered from devices returned to the company and thus likely doesn't paint a full picture. The more-definitive Medtronic data for that same model, in the entire patient population, show a failure rate of 2.3% over the same period.
As has been widely reported in connection with this Sprint Fidelis recall, when a defibrillator lead wire fractures the patient can get either an unnecessary and massive electrical shock to their heart or the defibrillator fails to deliver a life-saving shock after a cardiac arrest.
We will continue to monitor and report developments regarding what is known about defibrillators with Sprint Fidelis; in particular, the rate at which they have fractured and harmed patients implanted with such a heart device.
P.S. For some background on this October 19 WSJ aricle, visit the Dr. Wes blog post listed below and read the comment submitted by Northwestern University pediatric cardiologist Wayne H. Franklin, M.D.
"Kick 'em When They're Down"
We appreciate the insight from this discussion over at the Dr. Wes blog. (11/6/07)