Broken Lead Wires

 Broken lead wires are at the "heart" of a new controversy involving Medtronic.  Medtronic cardiac electrodes that were sold under the model name Sprint Fidelis have been recalled.  These cardiac electrodes connect the cardiac resynchronization therapy defibrillator to the heart.  Used in CRT-D devices implanted into defib patients, these wires have been used over 268,000 times.  Thus, there are a frighteningly large number of patients at risk.  The failure rate has been reported at 1%, but past FDA statistics show that adverse events can be 10 times greater than reported.  This means that many people may not receive the protective corrective shocks when life-threatening heart rhythms occur.

Attorneys at our office, familiar with the previous defibrillator class actions, consolidated Medtronic cases, and the Medtronic multi district litigation for the heart device recalls have begun working now of defibrillator lawsuits for the recent recall related to the wires breaking.  While we have suspected for a long time that this could be a problem, our suspicions are now being confirmed as the FDA has issued a warning about these defibrillator wires and Medtronic has issued a worldwide suspension of distribution of these thin wires. 

FDA Action

To read about the FDA recall, see the FDA frequently asked questions page, located on the FDA web site.   Doctors are being advised by Medtronic to stop implanting these leads.  The FDA considers this action to be a medical device recall.  The FDA is advising patients to check their patient device ID card to determine if these leads were used.  If patients are uncertain, they should check with their physician immediately.

Warnings Given

We are alerting all of our clients about the problems related to the defibrillator wires and urge anyone who has questions about this to consult their doctor immediately.  Medtronic makes all the models in question under the brand name Sprint Fidelis.  However, again, we suspect that the recall could be much larger, as it is possible that Medtronic supplied these leads to other manufacturers of heart devices.  Discovery documents will reveal if we are correct in this concern.

Lawsuits Filed

If you or someone you know has received a Medtronic defibrillator since 2004, please contact our offices for a free case evaluation.