Medtronic Sprint Fidelis: Texas Man Says Failed Leads Caused PTSD

February 12, 2008, 7:00AM. By Paul Halpern

Marshall, TXLarry McCall, a resident of this southeast Texas town, had an implantable cardiac defibrillator (ICD) in his chest. It was intended to monitor his heart condition, and if necessary, deliver an electric shock to his heart that would restore its normal rhythm. Problem is, that ICD was made by Medtronic and used its Sprint Fidelis leads. Those thinner-that-usual leads sat in his heart, and in 2006 they fractured.

According to McCall (not his real name due to ongoing legal action), beginning in January 2006, the defective Sprint Fidelis leads started delivering shocks to his heart at random intervals—shocks that he didn't need. It happened again and again ... and again...

McCall was just one of nearly 270,000 people worldwide with defective Sprint Fidelis leads. Medtronic withdrew the Sprint Fidelis from the market in October 2007 after receiving reports of several patient deaths. People like McCall, however, were caught between a rock and a hard place: removing and replacing the Sprint Fidelis leads requires delicate surgery that can be more dangerous than leaving them in place.

The federal Food and Drug Administration (FDA) said on its Web site, "The leads continue to function properly in the vast proportion of patients." McCall wasn't one of the vast proportion, though; he required emergency surgery to replace the Sprint Fidelis leads. In the aftermath, he says, he still suffers from heart palpitations and other related ailments; he says that he's also at increased risk of heart attack, potentially fatally.

McCall has filed suit against Medtronic for violation of several laws, including the Texas Consumer Protection and Deceptive Trade Practices acts. According to McCall's legal complaint, he's suffering from symptoms of Post-Traumatic Stress Disorder (PTSD) such as fear of death, anxiety, and "great physical, emotional, and psychological suffering."

Even with the defective Sprint Fidelis leads removed, the complaint continues, McCall believes that he will still suffer "severe physical injuries and/or death, severe emotional distress, and economic losses and consequential damages". The complaint also charges that Medtronic knowingly inflicted severe emotional distress or acted with reckless disregard, causing McCall "severe emotional trauma, physical consequences and long continued emotional disturbance."

That "reckless disregard" includes Medtronic's failure to issue any consumer warnings between March 2007, when the Sprint Fidelis lead problem first emerged, and October 2007, when they issued the recall.

Finally, McCall charges Medtronic with civil battery, arguing that the repeated shocks he suffered from the defective Sprint Fidelis leads were "a great physical blow" and "unprivileged physical touching."

McCall's case is not as unique as it may sound. The AttorneyPages Web site reports that many patients who have gone through what he has "have reported feeling fearful of having another surgery because of what could happen when they are on the operating table—such as having a heart attack, stroke or getting an infection. Even if some of these circumstances are unlikely to occur, it doesn't mean that patients aren't experiencing legitimate fear. Even patients who don't need to have surgery report that they're nervous about the future."

That's not what you expect or deserve from a medical device that's supposed to save your life.