Subjects: Quality and safety
Eight months after an astute cardiologist discovered a potentially life-threatening problem involving cables that connected Medtronic’s Sprint Fidelis defibrillator to the heart, the medical device giant pulled the product off the market.
By that time, five people had died and the toxic asset had been deposited into the bodies of 250,000 patients where they remain to this day.
Physicians are left to decide on a case-by-case basis whether to ride out the storm or risk a dangerous procedure to remove the cables.
The cables tend to crack causing the charge-box to either deliver shocks at inopportune times or fail to discharge at the moment of truth. Medtronic estimates a 5% cable failure rate at 45 months after implantation.
Cable extraction is dangerous because they end up becoming encased by fibrous overgrowth in the veins draining directly into the heart. The tricky dissection has already been associated with 4 deaths due to hemorrhage.
“We are just seeing the tip of the iceberg,” Ohio State University cardiologist Charles Love told the New York Times.
The procedure is best performed by cardiologists skilled in such removals, but such experts are harder to find than a PCP in Boston.
Medtronic has so far been protected from lawsuits by a Supreme Court decision involving another device in which it was decided that device makers can’t be held liable for products that have been approved by the FDA, a decision that seems inconsistent with its findings in Wyeth v. Levine.
Medtronic’s position is that the cables should be replaced only as a last resort. It covers the costs of replacement cables, but not the procedure which typically runs a cool 15 grand.