The Spring Fidelis (heart defibrillator lead wire) by Medtronic Inc. was recalled for safety reasons in October 2007. Implanted in approximately 268,000 patients throughout the world, the lead can fracture in some cases and cause the device to shock patients or stop working.

Because the lead can become embedded with scar tissue in the vein, Medtronic had advised doctors not to remove it, stating that it was riskier than leaving it in. An independent panel of physicians found that four of the 13 deaths linked to the lead happened when the extraction procedure occurred.

According to Medtronic, the panel could not determine the cause of death in the reports for sure because many of them appeared to be filed by family members or plaintiffs' lawyers and not medical professionals.

Recently, federal judges threw out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.

Democrats in Congress are working to pass legislation to overturn that decision.

Read DOTmed's extensive prior coverage:
https://www.dotmed.com/news/story/8382

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