Medtronic recall issued due to defibrillator lead problems raises questions for many
Over 235,000 people have been exposed to the risk of serious and potentially fatal injury as a result of a defective defibrillator lead which was sold by Medtronic, Inc. The Sprint Fidelis lead was recalled on October 15, 2007 after data confirmed that it was prone to fractures which could cause the device to fail or result in unnecessary electrical shocks. Many individuals who have one of the recalled leads now question why the Sprint Fidelis was used instead of an older, thicker wire. In addition, many are questioning whether they ever should have received a defibrillator to treat their heart condition.
>>INFORMATION: 2007 Medtronic recall
The Medtronics Sprint Fidelis lead is a small electrical wire used with implantable cardiac defibrillators, also known as ICD or CRT-D. The wire connects to the heart muscle to monitor the beat and deliver a life saving electrical charge if an abnormal heart rhythm is detected.
When it was introduced in September 2004, the Sprint Fidelis lead was the smallest defibrillator wire available, replacing the Sprint Quattro which was introduced in 2001. Medtornic, Inc. is a global leader in heart devices and they heavily promoted the thin wire to gain a competitive advantage over other cardiac device companies. As a result, many doctors elected to use the Sprint Fidelis lead.
While the smaller lead does make for easier insertion, there are no established long term benefits of a smaller wire. After the Sprint Fidelis lead was placed on the market, Medtronic received reports of defibrillator problems where individuals suffered unnecessary shocks or the device failed to properly function when it was needed to deliver a life-saving treatment. Despite evidence of problems with their lead, they delayed issuing the recall, exposing thousands to an unnecessary risk.
>>PRIOR POST (11/1/2007): Medtronic recall could have come earlier
In the wake of this recall, many have questioned the widespread use of defibrillators in the United States and whether the devices were the best treatment option for many who have one of Medtronics leads. While the devices are credited with saving lives every year, some doctors choose to treat patients with medications instead of an implanted defibrillator. Data has suggested that as many as 80% of the individuals who receive a defibrillator never need the life-saving electrical charge.
Sales of the heart devices to Americans in 2006 accounted for more than $4 billion of the $5.6 billion global market for defibrillators. This was partially due to heavy marketing campaigns designed to convince doctors that their patients should be referred for one of the devices. Medtronic even ran a brief advertising campaign which was directed to patients, as opposed to doctors.
MEDTRONIC DEFIBRILLATOR LEAD RECALL LAWYERS
The lawyers at Saiontz & Kirk represent individuals who have had one of the Sprint Fidelis defibrillator leads implanted (model numbers 6930, 6931, 6948, 6949). Medtronic recall lawsuits are being reviewed regardless of whether defibrillator problems have been caused by the defective leads. If you, a friend or family member believe you may have one of these leads, request a free consultation.
21 Comments • Add Your Comments
emma says:
We are very concerned about this problem I to have one of these leads I am worried everyday about this I THOUGHT i WAS prolonging my life NOW IT SEEMS AS IF WE ARE WALKING TIMEBOMBS WATING TO GO OFF AND NO ONE IS GIVING US MUCH INFORMATION ON THIS PROBLEM. I JUST GOT MARRIED AND NOW I AM WONDERING WHAT IS GOING TO HAPPEN I DONT WANT TO PUT MY HUSBAND THROUGH WATCHING ME SUFFER WITH THIS LEAD.SOMEONE TELL ME WHERE I CAN FIND OUT INFORMATION ABOUT THIS
Posted on January 2, 2008 at 9:37 am
mary mazzone says:
please inform me of the device as my husband is being told he needs one…thanks mary It is not safe
Posted on January 3, 2008 at 2:38 am
Austin Kirk says:
Mary, They are no longer implanting the recalled Sprint Fidelis lead. Therefore, you and your husband should contact his doctor to review any concerns you may have about whether a defibrillator should be used.
Emma, for additional information and a free claim evaluation, please feel free to contact our office toll free at (800) 522-0102 or click here. Additional information about the recall and the lawsuits visit the Medtronic Recall area of our site.
Posted on January 3, 2008 at 11:18 pm
wendy says:
I was on the patch for three years now,I have a rash on my chast called pityriasis rosea. The rash is frequently preceded by a “herald patch” and will not go a way like a virus. I 26 years old and it looks bad.
Posted on January 11, 2008 at 8:01 pm
Linda says:
My husband had his difibrillator implanted July 30,2007 he dies from complications on August 20,2007 3 weeks later. He also had the drug coated stent implanted in April of 2007
Posted on January 15, 2008 at 10:58 pm
Kathy says:
My husband has one and it is on recall and so does his sister in law and does Medtronic understand what this is doing to not only our loved one but to the family? We don’t know how they feel but we see the fear on their faces and it is killing the family to watch and see what is going to happen.
Posted on January 22, 2008 at 12:58 pm
carolyn says:
i have the device and my concerns are like everyone will it give shock and when not give shock and i’m also on medication, i went into congestive heart failure, i’ve never in my life every been sick are any problems but this changed my life.i am hoping this get resolved,i worry because i think i will have heart attack its really scary.and i have grandchildren i try and talk to everyday on regulard bases thinking something might happen to me.
Posted on January 29, 2008 at 9:36 am
Pat Campbell says:
I am concerned about getting truthful information from my cardiologist. We are told by Medtronics, and by the FDA that if we have questions we should consult our doctor. I went to my doctor with a list of what I thought were important, relevant questions to help me manage the problem and decide if I should have the lead replaced. My doctor was more interested in telling me that I didn’t have a problem, he was more interested in defending himself, in downplaying the issue, than answering my questions. In fact he did give me answers that contradicted information given already by Medtronics. I believe he was more interested in protecting himself from lawsuit than in helping me. I was more interested in protecting myself and not at all intersted in suing him…..but what is a patient to do. Medtronics says check with your doctor. Your doctor is defensive and possibly not answering questions in your best interst!! When I called another cardiologist and asked for a consultation for second opinion on the recalled defibrillator, there was hesitation, but I was granted an appointment. I have not yet had my consultation but I am hoping that it will be helpful. Pat C.
Posted on February 5, 2008 at 4:40 pm
JJG says:
I’d like my ICD removed and the leads capped. Any chance?
Posted on April 11, 2008 at 7:44 pm
burn says:
Such was the case with my father. The pacemaker was going wonky, perhaps because it had 2 leads and one of the leads did not connect properly and was hanging. Anyways it would pace up to 300bpm. After being treated by ambulance twice, they installed a defib. in him instead of replacing the faulty pacemaker. The defib. failed to work after 3 years. NOTE: after the install of the difib. his health steadily declined. When a electro/mechanical part is broken it should be replaced, not monitored and controlled by another electro/mechanical part. He has passed away. The machinery was a waste of time and great pain to him.
Posted on September 9, 2008 at 5:49 pm
Cathy says:
I have had the PaceMaker/Defib for almost 3 years I recieved a letter from Medtronic about the lead fracture possibility. They made it sound like it was a slight chance but to contact my heart spec.. I did, they also treated it as, just come by at your convenience and we will check it, it won’t take 2 minutes. I did that on an occasion a few weeks later when I was near the office. My doctors were in surgery, so I said I would come back. Before I could get back in, early on a Monday morning about 5:30 a.m. I was awaken by this kick in my chest that made me feel as if I had been struck by lightening from the top of my head to the tips of my toes. (I knew what had happened, because I had that experience on one other occasion, as soon as I could gather myself enough I leaned over to pick up my phone by the bed, it happened again. I had a very hard time even pushing the buttons on my phone to call my daughter, She said I will be right there. I tried to get up and it happened 2 more times, I was terrified and I knew I could not go by car, I thought I was dying right there in my bed. It happened two more times. I tried very hard to call the ambulance, I could barely speak I felt as if the life was just going out of my body, they could not understand me, finally i could not even hold the phone. The firemen and my daughter arrived together, of course she was just terrified. The ambulance shortly after. They rushed me to the closest hospital. Once there, we tried multiple times to give my Medtronic card to them, which did not matter to them. (They are supposed to call Medtronic as soon as a person arrives) After conferring with my heart doctor they determined that it was more than likely a fractured lead, and then called Medtronic who came within a half hour and turned it off. So I was in the ER about 6 hours before it was turned off. I feel that this is a very serious problem and is a very tramatic experience, 6 months since that horrible morning I still have what i refer to as night terrors and I am jarred out of a deep sleep thinking it is happening again. It is so real, there have been times I have called my daughter and she has come back to stay with me the rest of the night. This is not an easy fix. My doctor was very sympathetic the first visit and we had surgery the next day, he even said he wasn’t even going to charge me, he felt so bad for what I had been through. Well I do not know what he did not charge me for because I have been billed for every single thing anyone has even thought I needed done. I sure hope this has been helpful to someone, I would never want this to happen to another. Merry Christmas to everyone.
Posted on December 18, 2008 at 3:47 pm
Diane says:
My dad had a defective defibrillator so it was ‘repaired’. Now there is some sort of concern about the battery being to strong for the pacemaker – so basically if it goes off, due to the power, he would die??? Does anyone know anything about this concern that seems to be cropping up?
Posted on February 12, 2009 at 7:02 pm
desiree says:
i am 29 years old and had a defibrillator placed in me when i was 28,,after nine heart stents placed in.ever since i got this thing placed in me i’ve had nothing but trouble.fisrst it got infected then began to shock me.i talked to the dr who just says everything is fine just keep monitoring it.i’m to youg to have this on my mind,,it worries me daily and greatly affects my life and future.
Posted on April 1, 2009 at 2:50 pm
james says:
what are the alternative treatments?can’t get a straight answer from the electro guys who want to make 40k a pop. does vt qualify for a must implant of a device?
Posted on May 21, 2009 at 12:49 pm
Mavis says:
My husband had a Medtronic defibrillator put in Dec 08 March of this year he had to go back in because of a blip coming up on his monitor. So after a 270 mile trip back to the hospital, they installed a new unit. It seems their was a problem with the lead in the other wich could have produced a shock, of course we wouldnt have known if the shock was from the faulty lead or a real heart problem. Now this is two hospital stays, and we have to pay $500 deductable for the Dec 08 visit and now the Mar 09 visit another $500 deduct. We cant afford this everytime their is a problem. When I called Medtronic to inquire what there responsibility was, I was told they would re-view the case if it was indeed their product was at fault. In other words “dont call us we will call you” I am worried when my husband drives, he is 81 ,if he has a shock will he be capable of pulling off the road? Wow! all this is really bad.
Posted on May 21, 2009 at 3:25 pm
Joy says:
I’m 33 & have had 4 ICD’s since 2004. The first one, the lead didn’t take, secound one, it was suppose to go off, but didn’t. The third one, woke me up at 4am shocking me. Worst feeling ever!!! It shocked me 36 times before they could turn it off. My head has never been so mest up, until this happened.
So, I wounder if I would be able to call 911 while this thing shocks me. Will my phone blow up when I get shocked? I know the EMT’s felt me get shocked. And driving or just being in public and have this thing shock me again. Getting shocked by a life saving device for no reason is the most tramatic thing for anyone to go through. Good luck to everyone that has one of these devices.
Posted on September 19, 2009 at 2:35 pm
marcus says:
I got my ICD put in 2006. on 11-22-09, at work I was shocked 9 times before they turned it off in the emergency room. they told me lead falure. The shocks did not cause any health issues, but just scared the hell out of me.They replaced the lead and ICD. I am only 40 and in good shape. I do 3 miles of brisk walk a day and medication. My heart has made some improvements. do not be affaid of the ICD because it may save your life some day. I meet people who had the ICD for years and had problems with it, they are still alive; and some the ICD saved his or her life. Please enjoy your life, ask god for peace, then you will be alright. God bless you all and Merry Christmas 12/04/09
Posted on December 5, 2009 at 12:07 am
Brooke says:
My device was installed in Aug 2006. I was 30 years old. I went in last week to have the battery (device) changed and during the procedure my lead (A RECALLED LEAD) Fractured.
I was never informed about this lead being recalled. I (nor my doctor) had any idea it was a recall lead. The risk was too great to remove the bad lead or put a new one in. I now have a new defib device that is not even turned on. I am looking at many dangerous surgeries to remove the fractured lead and implant a new one, not to mention the constant worry that the fractured lead will dislodge or worse yet that I might need my device and it is not turned on…………does anyone know what I can do to get some help?
Posted on August 13, 2011 at 6:41 pm
A G says:
Had mine installed June of 09′ Today 1-14, it fired six times ,went to the
ER and they turned it of, ,damaged lead. damn that hurt,
Posted on January 4, 2014 at 3:50 pm
Sheila says:
I had my first Icd put in May 4th 2003. It was a medtronic. It would shock me constantly so that was finally corrected.
Then on Jan 13th 2012 they had to replace the ICD so my doctor decided to go with the St. Jude defibrillator. Low and behold this one is on the recall list.
Its bad already having a severe heart condition now we have these doctors and big companies that cause more problems for us.
Posted on March 29, 2014 at 6:15 pm
Lita says:
I received my pacemaker defibrillator in May of 07. I had a, what the doctors call, an oops. I was shocked 4 times in a row, and it scared the hell out of me. I found out I had one of the defibrillators they have the leads that are being recalled. I received a check from Medtronic 4 $465 from the class action settlement and was told that that would be all seeing how my lead had not fractured yet. I was told that if it did fracture in the future they would have no obligation to take care of it. I now have had my lead fracture I was told that I could leave it in and just have another lead put in with it or take that fractured lead out. If I choose to take the fractured lead out the laser they used to extract it could puncture a hole in my heart. What the hell?!!!!? Will the fracture lead parts damage my insides? I have had my pacemaker defibrillator for 12 years and 3 months and the doctor that put in the pacemaker retired right after and the doctor I have now has recently retired so now I’m waiting for the hospital to find me a new doctor. I worry everyday I’ve mostly become a shut-in and I hate it I feel like I’m always sick. Does anyone have any advice for me? As you can tell I really need it right now. How are people that supposed to help you, screw up your life even more? Thanks for reading.
PS: by the way that $465 I received, that will be all that I be will be getting. How can they implant something in your body and then we call it and say Here’s a little bit of cash. Hope it helps!!! What the hell? Don’t know what else to say. Well I do but I don’t think I should write those kind of words LOL
Posted on August 20, 2019 at 2:45 pm