A woman claiming that she received 47 unnecessary jolts from her Medtronic defibrillator is suing the company for emotional distress and negligence. The suit was filed directly before Medtronic issued a recall of its Sprint Fidelis defibrillator lead on October 15, 2007. The company says that the timing of the suit and the recall were purely coincidental.

According to the Associated Press, the lawsuit claims that the plaintiff had to go to the emergency room after experiencing “frightening episodes of unnecessary shocks . . . over and over again.” The suit further claims that the plaintiff was forced to have her defibrillator wire removed and that it “scarr[ed] her already fragile heart and force[d] her to undergo additional and unnecessary surgery.”

The recall

Medtronic’s recall of its Sprint Fidelis defibrillator lead affects 235,000 patients who have had the device implanted. The company estimates that up to 5,000 of those patients may have leads that are defective. However, according to the Food and Drug Administration (FDA), there is no specific test to determine which leads might be defective. The FDA and the company are advising patients to see their doctors to determine how to proceed.

Why wasn’t the product recalled earlier?

The FDA has reported receiving nearly 600 complaints about the Sprint Fidelis lead as of January, 2007 – some of those involving patients being unnecessarily shocked like the plaintiff above. It’s causing many to wonder why the FDA did not force Medtronic to recall the product earlier. Patients who recently had an implant of the Fidelis are especially upset as they may have to undergo another surgery to replace the device so soon after having the first surgery.

More lawsuits expected

Legal experts are expecting more lawsuits to be filed against Medtronic as health experts have explained that the procedure for replacing the leads can be risky as the lead connects the defibrillator device directly to the heart and requires surgery. Patients, such as the woman who brought suit above, have accused Medtronic of knowingly selling defective leads.

Additional information

If you or a loved one has been injured or died as a result of this device, contact an attorney immediately. To contact an attorney near you whose practice focuses in this area of law, click here.