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A story published in the Wall Street Journal claims that Medtronic may have had knowledge of problems with their Sprit Fidelis defibrillator leads as far back as February but did not act until October. Last week the FDA issued a Class I Recall on the leads in question after two reports surfaced of people experiencing unwarranted shocks from their defibrillators. One 65-year-old woman claims that she was “zapped” 14 times in only one hour.

Physician Robert G. Hauser says that he and other colleagues told Medtronic that there were problems with the device in February. The story claims that Medtronic replied by suggesting that physician technique was probably the reason for the alleged problems.

A Medtronic spokesman told WSJ that the company didn’t hide the problems or delay revealing them. Medtronic, he said, couldn’t rely on data from individual hospitals and needed time to complete its own statistically sound analysis and confirm was an excessive failure rate with Sprint Fidelis. “Physicians disagree on the data,” he said. “Some still think this device should stay on the market.”

The issue here is a difficult one. Medtronic tried to make a very thin lead to avoid complications such as blood clots that are associated with thicker leads; however, the thinner a lead is the more likely it is to fracture. This is a double-edged sword and has now put the company in perilous situation.

For more information on this subject,please refer to the section on Drugs, Medical Devices, and Implants.

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