Medtronic Fidelis Pacemakers
In October of 2007 Medtronic a leading manufacturer of biomedical devices was forced to recall one of their products. Recently the company decided to switch leads on their pacemaker. The Quattro lead is much thicker and more difficult to thread through into the heart. The new Fidelis lead is much thinner and were thought to help out surgeons during the procedure. The fidelis leads were later discovered to fracture, though. This could either cause the signal to not get to the heart or it would corrupt data that the lead collects. Corrupted data would cause the pacemaker to make erratic beats. If misfires of this sort happened to rapidly it would induce heart attacks. This problem had already attributed to five deaths by December of that year only 2 months later. The company itself came out that the failure rate was 2.3% of patients who have already had the pacemaker for three months. This would, on a bigger scale, affect 5,000 out of the total 235,000 who have received these implants.
The company did assume responsibility for this problem and began to immediately recall them. They promised to pay for some of the cost of the lead replacement surgery. This compensation was fairly insufficient, for they only contributed $800 out of the total $12,500 cost of the surgery. Besides that the people who actually needed the surgery didn’t know they needed until it was too late. No one knew who was in that 5,000. So often times, against their physician’s recommendation, wanted to receive the replacement surgery just to be sure they would be okay.
Afterwards, the FDA met with some other regulatory organizations to try and come up with a better system for making sure that the new biomedical devices that were being put on the market were tested. This could surly be considered one of the largest biomedical device disasters, solely due to the large numbers of potential subjects and the large number of uncertainty.
Gibb, Gordan. “Medtronic fidelis lead: a nightmare for patients.” Lawyers and Settlements.com. 2007. Online Legal Marketing Ltd. 22 July 2008.
2 comments:
I am surprised that they didn't give larger compensations for the replacement surgery. It seems like it would be easier to completely take care of the problem by fixing it than to leave patients dissatisfied with the potential of a lawsuit. A big medical name should be more careful. I liked how you presented the background on the faulty device before diving into statistics. The memo was really well written.
A big problem with biotech companies is that since so much money and time has gone into the development of products, they are reluctant to admit that their device is faulty (which would have a negative impact on their future business - plenty of biotech companies have gone under for far less). The reason they probably didn't completely take care of the problem is likely because doing so would have meant that they were acknowledging that their device has problems.
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