Shares of medical device maker St. Jude Medical could face pressure Monday on a media report that raised safety concerns over some of its defibrillator wires. 

The Wall Street Journal reported Monday that in rare instances, the company's Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall.

The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration.

The newspaper said the most recent cases involve the accounts of four patients and are expected to be posted online Monday by the medical journal Pace.

In October, Medtronic Inc., recalled its Sprint Fidelis lead wires after conceding that the device broke more often than expected and said five deaths may be attributed to the failures. The consumer advocacy group Public Citizen has said the FDA received 27 failure reports on Sprint Fidelis leads in the first two months of 2006. That figure surged to 152 reports during the first two months of 2007.

St. Jude said Monday it has sent a response to the Pace journal, which is expected to be published in the December issue, reaffirming the Riata leads performance and safety. The company said its data show that the incidence rate of perforations with Riata is below or at the low end of what has been reported in clinical literature.



We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Beasley Allen representing clients injured,...

The excruciating jolt that rings through one's body when his implanted cardiac defibrillator misfires...

Lead Shocks Send Patient to Psychiatrist

A patient affected by Medtronic's 2007 recall of defibrillator leads is suing the company, claiming...

Defibrillator Sales & Service Companies

The American Heart Association says sudden cardiac arrest claims 900 plus lives a day. And for those...

Poor FDA Scrutiny of Medtronic Sprint Fidelis Lead

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it...

Medtronic Settles Defective Defibrillator Lawsuits for...

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that...

Recalled Heart Implant Gives Man Shock Of His Life

In early December, Jerry Jackson received the shock of his life. Or six. The 63-year-old Mineola...

Wonderful to work with

Beasley Allen did a great job with my case. They were wonderful to work with. They were available by phone when I needed them, treated me with the utmost respect and worked hard on my behalf. If a need arises in the future, I would definitely call on them again.

—Geraldine