St. Jude defibrillator leads could puncture a hole in heart

Austin Kirk

By Austin Kirk
Posted November 13, 2007


UPDATE 2012: Following reports of St. Jude Riata leads puncturing the insulation around the wires, a recall has been issued for Riata and Riata ST leads. The lawyers at Saiontz & Kirk, P.A. are now reviewing potential St. Jude defibrillator lead lawsuits for individuals nationwide.

Last month, Medtronic issued a recall for their Sprint Fidelis defibrillator lead after it was discovered that the lead was prone to fractures.  Yesterday reports were released which indicate that other defibrillator leads made by St. Jude Medical, Inc., could contain a design flaw which makes it more likely to puncture a hole in the heart.

Defibrillator leads are small electrical wires which connect the defibrillator to the heart.  The leads attach to the heart wall to sense when the heart’s rhythm becomes too rapid, in which case it is supposed to deliver a life saving electrical shock to restore a normal rhythm.

According to an article published yesterday in the Wall Street Journal, there have been reports that the St. Jude Riata leads could poke holes through the heart instead of staying attached to the heart wall.  In some of the reported cases the leads nearly went through the outer layer of skin after protruding through the heart. 

If a defibrillator lead punctures a hole in the heart, it could cause the defibrillator to fail when it is needed to deliver a life-saving shock, or blood could escape through the hole, resulting in pressure around the heart which could be fatal.  The St. Jude Riata defibrillator lead has been associated with several deaths and dozens of reported problems where the wire perforated the heart.

The medical journal Pace is publishing a report which contains details of four cases where the St. Jude defibrillator lead caused a heart perforation.  Researchers indicate that there may be inherent design flaws in the Riata leads which could increase the risk of a heart perforation.  Some doctors have indicated they have stopped using the leads.

Over 120,000 St. Jude Riata defibrillator leads have been implanted in heart patients.  St. Jude indicated to the Wall Street Journal that their data shows the defibrillator lead perforation rates for the Riata leads are lower than those reported for other defibrillator leads.  However, the Wall Street Journal indicates that other data reported from several hospitals found a much higher perforation rate than was cited by St. Jude.


The lawyers at Saiontz & Kirk, P.A. currently represent clients nationwide who are pursing defibrillator lead lawsuits following the October 15th Medtronics recall.  Research is now being reviewed to determine if a design flaw may be responsible for the St. Jude Riata lead causing heart perforations.  If you, a friend or family  member have experienced a defibrillator lead puncturing a hole in the heart, request a free consultation.

1 Comment • Add Your Comments

  • Kimberly says:

    I received my first St Jude defibrillator at Redmon Regional in Rome, GA I saw Dr Smith & Dr Sims at Emory Heart Failure Center in Atlanta, GA for approximately 3 years and due to the long drive I switched to CHI Memorial in September 2015. Upon interrogation of defibrillator, it was completely dead and was replaced on Sept 29, 2015. 2 weeks after 2nd implant I started having stabbing pains in my chest. ER visit on 10/16/15 I was diagnosed with pleurisy and sent home. Pains grew worse so 2nd ER visit on 10/24/15. They discovered lead wire had gone thru my septum and heart. I was put in CVICU for 4 days until wire was pulled back thru my heart pn 1//27. I was discharged on 10/29. Back to ER on 10/30 with fever. I had become septic. 2nd defibrillator and all lead wires removed 11/2 & wound vac put in. High doses of vancomyacin until wound vac removed on 11/5. Then began ancef. Discharged with Zolo Life Vest on 11/7. I have suffered tremendously from the wire puncturing my heart and am now afraid to get another defibrillator but I cannot wear this life vest forever. My heart throws trigeminy pvc’s on a regular basis. My left ventricle is severely dilated and has sever dyfunction. What help is there for me?

    Posted on November 11, 2015 at 2:02 pm

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