Medtronic, the maker of Sprint Fidelis, a heart defibrillator cable, has taken its product off the market. But the problem with it still being used by some 150,000 people around Illinois and the country has resulted in several deaths in removing the defective cable.
Medtronic estimates that the cable has failed in a little more than 5% of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.
Already 4 patients have died during extractions. It is feared that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of these operations.
“I think we are seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at who specializes in cable extractions. For many patients around Illinois, the big issue is who is skilled enough to remove these defective heart implants. It is thought that some surgeons removing the cables do not have the required skill level.
In the meantime, Medtronic has said that regardless of whether the Sprint Fidelis Cardiac Lead is broken or working, it should only be extracted as a last resort. The company did not know how many of those defective cables had been extracted.
The Heart Rhythm Society, a group representing doctors who implant heart devices, plans to issue guidelines about cable extraction this year. They would urge doctors to perform at least 30 removals under the supervision of an experienced surgeon before doing it solo.
Some experts say that it is difficult for doctors to obtain this high level of training. They caution that even well trained physicians need to regularly perform significant numbers of extractions to remain competent.
For over 30 years Kreisman Law Offices has been handling Illinois defective medical device liability lawsuits in areas in and around Cook County, such as Wheeling, Calumet City, Chicago, and Orland Park.