A patient with Medtronic’s Sprint Fidelis defibrillator lead that was recalled in 2007 is suing the medical device maker for Post Traumatic Stress Disorder (PSTD). The man claims that he received unexpected shocks from the device and those that constitute civil battery (an unwanted touching) that were so severe that he now suffers from PSTD and has to see a psychiatrist. The patient had to undergo emergency surgery to have the lead replaced and is reported to now suffer from heart palpitations and anxiety.

Other patients report similar experiences

This patient is not the first to report being unnecessarily shocked by the device, which has already been linked to five deaths and affects 235,000 patients worldwide. Another patient claimed that she received 47 unnecessary jolts from her Medtronic defibrillator is suing the company for emotional distress and negligence.

The Associated Press reported that her lawsuit claims that she 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.”

These are only two of the hundreds of frightening experiences being reported by patients around the country. Patients who have experienced these episodes say that they feel as though they are having a heart attack, which ironically, is what the device is supposed to prevent.

Defibrillators

Defibrillators are also known as implantable cardioverter-defibrillators (ICDs) or automated implantable cardioverter-defibrillators (AICDs). They are small electrical impulse generators that send an electrical ‘shock’ to the heart. The Sprint Fidelis lead that connects the device to the heart is the subject of Medtronic’s recall. According to reports, this defective lead may malfunction in at least one of two ways:

• Fail to shock the heart when a shock is needed
• Shock the heart when a shock is not needed

Model number subject to the recall

The Medtronic Sprint Fidelis model numbers in question are 6930, 6931, 6948 and 6949. Patients should have received an ID card with that information. If you don’t have it, contact the doctor that implanted the device or Medtronics at 1-800-551-5544, ext. 41835.

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.