Removing Defective Medtronic Leads May Pose Big Risk

Jean Martin
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Posted by Jean MartinApril 07, 2009 9:56 AM

Much has been posted about the dangers associated with the defective Medtronic Sprint Fidelis Leads. Just recently it was revealed that there are more deaths associated with this faulty lead wire than Medtronic had previously reported. Lawsuits for injuries due to malfunctioning of the Sprint Fidelis Lead wires have been dismissed on the basis of preemption - a simple meaning being that FDA approval prevents lawsuits under state tort laws.

Now to add insult to injury, the New York Times has printed a very alarming article about the difficulty in removing these lead wires. Not only have people died as a result of a malfunction of the wires, now people are dying as a result of doctors trying to extract the wires. The procedure is quite complicated and there are a few doctors who have the necessary experience to perform it. The deaths have resulted from damage to a vein or the heart during the risky procedure causing extensive bleeding. Even the physicians who have the most experience with explanting these wires are saying that the procedure presents many challenges to them.

It's really unfair that patients and their doctors have been put in this precarious position. And it's even more unfair that Medtronic might not be held accountable for their actions.

3 Comments

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JILL PAUL RN
Posted by JILL PAUL RN
April 07, 2009 12:57 PM

Thank you Jean Martin for bringing this to everyone's attention. My husband's fractured Sprint Fidelis lead was retrieved by an experienced Open Heart Surgeon, fortunately, successfully, but he did have to have a second surgery to extract a hematoma (blood clot) which had formed under his new Pacemaker/ICD. Most Electrophysiologists would have capped the fractured lead leaving it in place and threaded a new wire to the device. They feel the risks outweigh the benefits for retrieval. Thank you.

JILL PAUL RN
Posted by JILL PAUL RN
April 07, 2009 1:57 PM

Jean, after reading the article from The New York Times, I feel that I must make additional comments. My husband, who is 100% pacemaker dependent, was transported by ambulance to the nearest facility which just happened to be the Hospital where I work. After receiving 37 debilitating, horrific shocks, he was in no condition to be transferred to another larger facility where they might have had more expertise in extracting the fractured lead. We were just very fortunate to have an experienced Open Heart Surgeon available to us, who, I recall said, he had extracted 3 leads prior to my husband's - not 50. Medtronic offered us $600.00 towards the new cable for which we were billed $10,000. The new pacemaker/ICD was an additional $45,000 and it was only 2 years old. The longevity of a pacemaker/ICD should be 5-7 years, but, because of his multiple shocks, the battery was depleted. His hospital bill (including the new lead, Pacemaker/ICD and second surgery) amounted to $150,000. I don't know of any Hospital in the country where you could have this very risky, life-threatening surgery performed, for $15,000 to $20,000. I urge anyone reading this to contact their respective Congressmen/Women and Senators to support and co-sponsor "The Medical Device Safety Act" - 2009 - S540/HR 1346 - so that you, your Children and Grandchildren will not have to endure the pain and suffering that we have had to endure. Thank you.

Jean MartinInjuryBoard Attorney Member
Posted by Jean Martin
April 07, 2009 3:44 PM

Jill, thank you so much for your comments. Your account of your husband's situation definitely brings to light the real and human aspect of the harm that has been created by the malfeasance of Medtronic. I whole-heartedly support your urging that people contact their legislators to promote necessary changes to the Medical Device Safety Act. The changes are needed to ensure that good people like you and your husband, who have suffered harm at the hands of others, have recourse against these manufacturers.

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