Removal of "recalled" heart defibrillator cables presents difficult choice for pateints and families
In 2007, Medtronic recalled its Sprint Fidelis heart defibrillator cable because its thin wires were prone to fracture and had caused at least five patient deaths. The cable was approved by the FDA without adequate research. Now, the cables have been surgically placed in the bodies of more than 150,000 patients, who are faced with a Hobson's choice of undergoing dangerous surgery to remove them, or leaving them intact and praying that they continue to function properly.
Already four patients have died during surgery to extract the leads. The deaths have been attributed to heart or blood vessel damage suffered when inexperienced surgeons attempt to remove the leads from over-grown soft tissue. Authorities emphasize that removal is not "routine" and must be performed by highly-experienced surgeons. No one should allow the removal to be performed by a surgeon who performs fewer than fifty of these procedures per year: even for experienced surgeons it is very delicate and dangerous. Surgeons recommend that the first 30 extractions performed even by experienced surgeons should be supervised by another surgeon already well trained in extraction.
Medtronic concedes that five percent of patients have suffered lead failures within 45 months of implant. It has agreed to provide data on extraction mortality and complications to the FDA, however, it has so far refused to make that data public. Cardiac surgeons say that so far we have seen only "the tip of the iceberg," as patients' and their leads age. Under a recent U.S. Supreme Court decision, Medtronic is immune from liability for implanting the too-small, too-fragile leads, because the FDA approved them (under a grandfather clause requiring only superficial analysis of Medtronic's modifications to a prior device). This has resulted in the dismissal of more than 1,000 lawsuits seeking compensation.
Currently, Medtronic is supplying replacement cables, but patients, private insurers and Medicare are picking up the $15-20,000.00 tab for the removal. The cables were expected to last 15 years or longer. Where possible, fatigued cables are left in place and new leads are implanted without removing the old leads. Unfortunately, however, leaving the leads in place, where it is possible, further complicates susequent surgeries.