In 2007 Medtronic, the company that made Sprint Fidelis heart defibrillator cable stopped selling the product after five patients who had the cables died. But now that the cable is off of the market 150,000 heart patients are still using the cable. Now doctors are left with the task of extracting the cables which is proving to be a very risky procedure.
The cable failed in less than 5 percent of patients in the 45 months since it was first implanted. Many patients are opting to have the surgery to take out the cable because they fear that the cable will fail. The problem compounds because four people have died from the extraction surgery and the medical community fears that the fatality number will increase because patients may go to unskilled doctors concerning this type of procedure. Experienced surgeons have found this procedure to be difficult at best. The probability of one of these patients going to an unskilled surgeon is likely because there is very little data reported on the procedure and many hospitals do not publicly report the success rates.
To date Medtronic has had any financial legal implications for over a 1,000 patient lawsuits because they are protected by a ruling from the Supreme Court. The ruling was originally held for a different device protecting the makers from liability lawsuits on products that were approved by the F.D.A. Medtronic has offered replacement cables, but the cost of the surgery to extract the old cable and replace it with the new one can run from $15,000 to $20,000 and is being carried by Medicare and private insurance companies.
The main problem with the cable is that it has a tendency to crack which leads to electrical problems. With this electrical problem the cable may not shock the heart to fix a possible fatal rhythm or it may discharge repeatedly unnecessarily shocking the patient. Doctors are now faced with the decision to either initiate the risky procedure or leave the cable intact and hope that it works until the battery is drained. The cables batteries typically last for about 15 years.
The Heart Rhythm Society is urging doctors to perform 30 of these particular extraction surgeries under the supervision of an experienced extraction surgeon before they attempt the surgery on their own. The Heart Rhythm Society plans to issue guidelines on this topic within the year.
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