Rosenbaum Faria, LLP, has discovered this latest recall exceedingly alarming to clients already contending with other heart device-related recalls. Medtronic's October 2007 recall of its Spring Fidelis defibrillator leads is the eighth Class I recall for the heart device manufacturer.
New York, NY (PRWEB) November 2, 2007 -- Rosenbaum Faria, LLP, a Manhattan law firm involved in the Guidant defibrillator recall litigation has been reviewing medical records for its clients to determine which might be involved in the Medtronic Sprint Fidelis lead recall. The leads involved in this latest recall are the Sprint Fidelis lead models 6930, 6931, 6948, and 6949.
This latest Medtronic recall, the eighth Class I recall since 2004 for the heart device manufacturer, involves approximately 268,000 leads implanted worldwide. According to reports, if the current failure rate of 2.3% continues, approximately 4,000 to 5,000 people could experience a lead fracture during the first 30 months after the device is implanted. Approximately 172,000 of the leads were implanted in the United States.
"These leads could be attached to a Medtronic defibrillator or a device manufactured by someone else, so it's important that everyone check their implant cards even if they don't have a Medtronic device," said Cory Rosenbaum, lead partner in the firm. "According to the FDA, the defects in the devices could cause the wire to fracture or break, and that's scary news for people depending on these devices to save their lives. A broken lead can also cause a painful shock when no therapy is actually required."
According to Medtronic, the Sprint Fidelis leads are very fragile. They are a newer type of lead designed to be thinner than previous versions for easy insertion. Their former model of similar type, the Sprint Quattro, was replaced by Fidelis in 2004.
Upon initial reports from various physicians, groups, and hospitals, beginning in about January 2007, the FDA and Medtronic attributed the reported failures of the Sprint Fidelis leads to insertion errors and damage from handling the leads prior to and during insertion. The FDA did not require the Sprint Fidelis lead to undergo any strict testing as it wasn't considered significantly different from Medtronic's previous Sprint Quattro model. Human trials were required for previous models, but not this time.
According to advice from both the FDA and Medtronic, patients should not routinely seek removal of the leads. The risks of removal in most patients exceed the risk of lead fractures. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. Another is to surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. If the Sprint Fidelis is left in a patient without being used, the tip is capped with a small plastic insulator.
Said Cory Rosenbaum, "The FDA's agreement with Medtronic that defibrillator settings should be adjusted to help detect a lead failure seems like a reasonable measure at this time for many of these people. It's just frustrating to have to explain to clients that the FDA could have made the recommendation almost a year ago when the reports first started coming in. I sympathize with these heart patients. I mean, they expect that something that goes into their body to save their life will work when they need it. Now, they have to worry about this latest problem, even if they don't have a Medtronic lead."
"People with heart defibrillators who have concerns can phone our office to discuss the recall. We would be happy to speak with them. They can phone us at (212) 732-7922 daytime or evening. None of these heart patients should be walking around out there worried if they don't need to be."
Sources:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDS/MDSResults.cfm
http://www.fda.gov/consumer/updates/medtronic101507.html
Source: PRWeb: Legal / Law
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