by Carolyn Thomas ♥ @HeartSisters
It’s nail-biting time for hundreds of thousands of patients worldwide who have had a Riata defibrillator implanted next to their hearts (79,000 in the U.S., 5,300 in Canada, 4,000 in Australia – just for starters). The recent news about the Riata recall might feel like being told you now have a ticking time bomb inside your chest. Trouble is, you just don’t know if that time bomb will start firing when it shouldn’t, or fail to fire in time to resuscitate your heart when it should.
And worse, neither does your doctor.
In December 2011, following reports of premature erosion of the insulation around the electrical conductor lead wires in these devices, the FDA ordered an urgent Class 1 recall (the most serious type of recall) of all Riata and Riata ST Silicone Endocardial Defibrillation Leads manufactured by St. Jude Medical Inc. Here is the FDA recommendation to all patients with these Riata devices implanted in their bodies:*
“Patients should contact their cardiac physician to determine if they have the recalled leads, and to request additional information regarding care and monitoring. Physicians and patients should discuss the best approach to take based on individual need.”
Then the FDA got even tougher: a press release this week tells physicians that their patients who have one of these recalled Riata ICDs implanted should undergo “either a 2 view chest x-ray or fluoroscopy to check for abnormalities in the insulation surrounding the leads.”
Many cardiologists do not seem to like the FDA telling them what to do. Meanwhile, worried heart patients are curious about why more of their doctors are not screaming blue murder on their behalf, instead of demonstrating sputtering indignation about perceived FDA interference.
This isn’t the first case of an ICD recall, as all electrophysiologists will assure you. Over the past five years, device manufacturers like Medtronic, Boston Scientific and St. Jude Medical have had significant ICD issues resulting in device recalls. Let’s consider why heart patients are now moved to finally speak out about a recall.
But first, here are the basics of how this amazing little invention is designed to work: an implantable cardioverter defibrillator (ICD) is a small device that can be surgically inserted inside your chest if you’re at risk for certain types of heart arrhythmia, or if you have a heart condition that puts you at high risk forsudden cardiac arrest.
Your ICD has wires with electrodes on the ends that connect to one or more of your heart’s chambers to monitor heart rhythm. These wires connect to a small metal box implanted in your chest or abdomen. The box contains a battery, pulse generator, and small computer. When this computer detects irregular heartbeats, it triggers the ICD’s pulse generator to fire off electrical pulses; lead wires then carry these pulses to the heart. These leads typically have layers of insulation that protect electrical conductor wires inside the lead.
In the recalled Riata leads, it’s this insulation that’s been found to be defective – resulting in premature erosion of the insulation around the electrical conductor wires, known as insulation failure, as shown at left. (A study* reported in the medical journal Heart Rhythm, for example, showed that Riata’s structural lead failure with externalized cables like these was seen in 33.3% of patients, and 31% of the leads with exposed cables showed electrical failure).
When your ICD is working as it should, any irregular heart rhythm will trigger low-energy electrical pulses to prompt your heart to beat at a normal rate again. If these low-energy pulses can’t restore your heart’s normal rhythm, you might experience the defibrillator’s painful high-energy shock. One ICD patient described this shock to me as “feeling like somebody had thrown a baseball at my back as hard as they could!”
Even with leads that are working just fine, we know that ICDs can sometimes fire off unnecessary electrical pulses or shocks to the heart. These can be caused by damage to the wire, or by a very fast heart rate (likely due to physical exertion or forgetting to take your heart medications).
ICD pulses sent too often or at the wrong time can damage your heart or trigger an irregular, sometimes dangerous heartbeat. Patients – and their families – can find these shocks frightening and traumatic. The typical ICD recipient, even at the best of times, must overcome both the stress of experiencing a life-threatening cardiac arrhythmia as well as the challenge of adjusting to an ICD implanted inside their bodies. Some patients report the phenomenon of “phantom shocks”, in which an electrical shock is felt despite no recorded discharge from the device.
Indeed, clinical trials demonstrating the effectiveness of the ICD have focused primarily, as you might expect, on mortality outcomes – not so much on the quality of life issues affecting patients who wear them day in and day out. A number of studies have subsequently shown that in some ICD patients, however, the potentially reassuring and life-saving benefits of living with an ICD are outweighed by accompanying symptoms of anxiety and depression, particularly for patients with a “shock history” or for those who are under age 50. The reputation of the ICD as a “shock box” remains a significant source of anxiety to potential patients. Anxiety in fact is common – some estimates peg the percentage of clinically significant anxiety disorders among ICD patients at up to 38%.
And these are the ones who have not had their potentially defective ICD leads publicly targeted in an urgent Class 1 device recall.
But here’s the troubling reality now faced by patients who have had Riata ICDs implanted: the FDA, St. Jude, and the Heart Rhythm Society all recommend that these defective leads should NOT be routinely removed from patients (even if the cables have broken through the eroded insulating coating) because of risks associated with the surgery required to remove the leads.
In case doctors have not figured this part out yet, the scenario is your basic nightmare if you’re a patient now living with a Riata ICD.
Hugo Campos may well be one of the highest-profile ICD recipients around, famous among heart patients for his personal fight to be able to access his own cardiac data. Here’s an excerpt from what Hugo had to say in April in his pull-no-punches reaction to the Riata recall:
“In a world in which physicians’ views are sometimes marred by speaking fees and consulting arrangements with medical device companies, patients must rely on the media for information about recalls.
This is about the Class 1 recall of a lead that’s been implanted in 79,000 U.S. patients. These are people who, like me, were told the device would be there to save their lives in case they ever needed it, and who are now learning that this might not be the case.
“This is about how poorly the ‘the guys in the suits’ have handled this crisis so far: defensively and arrogantly. And how it reflects on their company’s image and reputation.
“Doctors and medical device companies should realize that a new world has emerged. It is a world in which patients are more empowered, equipped with information, and engaged in their care. We are connected through social media like never before and we are talking. We’re talking about doctors, therapies, brands of devices and even recalls.
“You can no longer control the message. Patients have the right to know. After all, we are the ones living with heart disease.
“That’s how WE put ourselves at the center of a device recall.”
Even the exact number of patients whose Riata ICD leads are defective is apparently uncertain, because the flaws are hard to detect with existing tests, and failure may not occur until an electric shock is needed.
Fran Lesicko, a psychologist who credits her ICD with saving her life nine times in the 11 years following her own sudden cardiac arrest, has this powerful reminder for us about the definition of “failure” in these recalled ICD leads:
“For many who have experienced sudden cardiac arrest and also have needed an ICD shock to save them, to have it fail means death.
“Hiding information from patients (‘what they don’t know won’t hurt them’) is deceptive and inappropriate. And it COULD hurt the patients.
“We used to have this attitude toward terminal patients, and now we know better.”
Even worse (and can it get much worse?), here’s what cardiologist Dr. Robert Hauser of Abbott Northwestern Hospital and the Minneapolis Heart Institute told his peers attending the American College of Cardiology 2012 Scientific Sessions in March:
“While investigators have focused on externalized ICD cables, our study suggests that the greater risk to patients is the loss of the insulating barrier between high-voltage components, particularly between an ‘outside-in’ abraded high-voltage defibrillator cable and the shocking coil or pulse generator can.”
Such short circuits are believed to be the cause of 22 deaths so far in patients with Riata leads described in the data Dr. Hauser presented at the ACC sessions, which were also published online in Heart Rhythm on March 26, 2012. He explained:
“Many of those deaths could not have been predicted; there were no signs. Generally, the ‘radiographically opaque’ shocking coils and generator cans will block fluoroscopy from showing how close they may be to insulation breaches.”
When interviewed by Heartwire in March, Dr. Hauser warned that, of the thousands of patients currently living with the Riata leads covered by the recall, some of them have insulation failures that are positioned in such a way that they are at risk of causing potentially fatal high-voltage short circuits “and there may not be a good way of identifying them.”
Meanwhile, as reported in Forbes recently, a recent St. Jude-sponsored physicians’ webinar about the Riata recall featured Dr. Neal Kay (who happens to have “consulting arrangements” with ICD manufacturers St. Jude, Medtronic and Biotronik) calmly reassuring his audience that “more than 85% of the externalized conductors continue to function normally.”
Dr. Bruce Wilkoff is the president of the Heart Rhythm Society, an organization that coincidentally receives over half of its annual funding from drug and device manufacturers – including St. Jude Medical Inc.
He was in Australia this week speaking at the 2012 Cardiac Society of Australia and New Zealand meetings in Brisbane. Australia’s Therapeutic Goods Administration (the country’s regulatory agency for all drugs and medical devices) had already issued a directive back in May to 4,000 patients there living with Riata ICDs: see your cardiologist, and undergo X-ray or fluoroscopy if you experience adverse events.
And speaking of adverse events, when such failures occur in the U.S., they are voluntarily reported by hospitals and doctors into a public FDA database called MAUDE, as Hugo Campos explains.
Manufacturers like St. Jude Medical Inc. are required to report deaths and injuries, but there are an unknown number of delays in adverse event reporting by all manufacturers. Thus the list of adverse events reported into MAUDE is incomplete. In fact, as reported by cardiologist Dr. Rita Redberg, testifying to the House Oversight Committee on June 2, 2011, only 5% of all adverse events are ever reported.
But I digress. Back to Dr. Wilkoff, who was speaking to a packed audience of doctors attending the Brisbane conference, where he dismissed Riata’s insulation failure problem with externalized leads as primarily just a “cosmetic” issue, adding:
“Externalized cables make you feel bad [but] we’re not treating how we feel.
“If you didn’t take a chest x-ray, you wouldn’t even know.”
I’m assuming from this kind of appallingly unfortunate word choice that neither Dr. Wilkoff nor any of his St. Jude pals are walking around with a Riata ICD time bomb ticking away inside their own chests.
Since I started following this story, I’ve observed growing online resentment from physicians over FDA’s recent attempts to interfere with their clinical practice by demanding x-rays or fluoroscopy of all U.S. patients implanted with the recalled Riata leads. As Dr. John Mandrola writes in his highly recommended Trials & Fibrillations column:
“It is an ominous precedent when a powerful agency inserts protocol and dogma into a situation best handled with nuance and shared decision-making.”
I was glad to see that Dr. John, unlike a number of his electrophysiology colleagues, at least acknowledges the most important party in this whole mess: the patient.
But here’s how he does it: he notes (in a surprisingly patronizing fashion) that “some patients would be devastated to know that their normally functioning lead had an externalization”.
The trouble is that, as Dr. Hauser has warned, a “normally functioning” Riata ICD lead today may very well be the cause of death tomorrow.
And as one Riata ICD patient (one of Dr. John’s column readers) responded to being thusly patronized:
“I’m the owner/operator of one of these leads, and I want a fluoroscopy, and I want to see the fluoro, at least if it’s abnormal.
“I’m sure that, as you write, everyone’s response thereafter might be different, but I for one want the information, then the doctor’s perspective, and then I want to decide.
“I’m one of those primary prevention people who didn’t sign up for the prospect of worrying about hairy looking leads floating around my chest. It’s already way more than I bargained for.”
Riata ICD patients are right to be worried, and yes, downright angry.
Why would patients be expected to meekly wait for “nuance” when what they deserve are accountability and safety?
Dr. Laurence Epstein of Brigham and Women’s Hospital in Boston admitted in an illuminating Heartwire interview that even the best ICD lead, when implanted poorly by a physician, is not going to survive. For example:
“Some ICD leads undergo quite a fair amount of stress. You can’t account for knuckleheads putting them in. Some lead failures are going to be expected, some of them just because of the harsh environment they’re in. Others fail because people put them in in horrible ways.”
I don’t know about you, but I find it distressing when cardiologists describe their professional colleagues as “knuckleheads” who are surgically implanting ICDs into their patients “in horrible ways”. And if this assessment is indeed true, someone please tell me what Dr. Epstein et al are doing to keep patients safe from the knuckleheads out there who want to operate on them.
Perhaps this is why some of us may actually be feeling genuinely grateful to the FDA for deciding that somebody, somewhere, has to finally do something to address this madness.
* Sunthosh V. Parvathaneni et al. “High prevalence of insulation failure with externalized cables in St. Jude Medical Riata family ICD leads: Fluoroscopic grading scale and correlation to extracted leads”. Heart Rhythm. Volume 9, Issue 8, August 2012, Pages 1218–1224
** Read the full text of the FDA Safety Communication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.
Portrait of Hugo Campos: Cristiano Siqueira
- Coping with your partner’s ICD and heart disease
- What heart patients want ICD makers to know
- Hugo Campos fights for the right to open his heart’s data: watch Hugo in this 9-minute TEDx talk
Q: Have you had a Riata ICD implanted?
23 thoughts on “ICD warning: defective defibrillator leads recalled”
Ok so iv started feeling a pinching throbing feeling in my chest. Now I know it feels like when the defibrillator goes off cuz I’ve had mine for almost 15 years but this weird pinching pain hurts when I breathe or when I adjust my upper body and it hurts on the lower side of my defibrillator implant never felt this before can’t find anything about it online has anyone else felt this or know that could be I just got this defibrillator replaced a year ago and haven’t had it fire yet
Logan, book an appointment to see your cardiologist immediately to get this checked out.
Hi good day..
I’m just wondering if someone could gave me advice of what to do after experiencing 42 shocks of my 2 in 1 pacemaker-defibrillator.
My device inserted almost 3 years ago here in Nepean Hospital NSW, Australia.. I mean nothing wrong with my heart I got perfect rhythm, in fact during that day I went to my GP to let him know what’s goin on with me and then did an ECG and the result is fine.
And the same day when I’m about to close my eyes, suddenly I experienced shocks and it’s randomly 3x in a row so we decided to call an ambulance as I know it’s not normal.
While waiting for 20 minutes I got 12 shocks, then on the way to hospital I got 5. They kept checking my ECG and they said it’s normal. While in the emergency it’s still keep going on until the doctor put magnetic something to stop it.
It stopped for a while but when he start pulling out my chest, the shocks fired again. I end up with almost 42 shocks for just 3 1/2 hours.
What I’ve been through is not acceptable especially I thought the device I got is to save my life but what happened is this will be the one who can put my life in danger.
I’m just 35 years old and I have 2 babies, I don’t want them losing a mommy. Now I am mentally exhausted and I not able to stop thinking what I’m gonna do now… At the moment I’m still waiting for my doctor to talk about this incident.
Please if you have any ideas help me with my bad experience, please thank you.
Aubrey, this is horrible! No wonder you are exhausted. You are correct – this is NOT acceptable. Whatever is wrong with your ICD, it must be identified and addressed as soon as possible. If this happens again, call for an ambulance immediately and do NOT leave the hospital (even if your ECG looks “normal”) until cardiologists have assessed the problem and actually done something to prevent it misfiring again. Best of luck to you…
I am 34 and experienced 34 shocks on December 5th 2018 and know how you feel. I am terrified daily.
34 shocks on one day!?! No wonder you are terrified, Jillian. What did your cardiologist say about this? And have you had any issues like this since December?
I am scheduled to have an ICD implant in the next month, but after reading all this info I’m not sure I even want one.
Is there a class action suit regarding the travesty? My son is having the procedure tomorrow to have this faulty lead replaced, we both are rightfully terrified. We are placing our worries in God’s hands. Very stressful situation.
The doctors say due to the age of my son (35), they do not recommend leaving the faulty wire in, and the best thing would be for them to remove it and replace it.
I’m so sorry you and your son have had to go through this, Karen. There was a class action suit launched shortly after the recall with about 1,000 patients represented. I’m not sure if the deadline for that suit has passed by now. You can find more info http://media.sjm.com/newsroom/News-Release-Details-St-Jude-Medical-Statement/. Talk to a lawyer for clarification.
Best of luck to your son tomorrow.
Had an ICD in July 2014. Bad infection, took out, another one put in October 2014. Having problem now. Seems like Doctors just want to dismiss situation. First one was Biotronik, second one was Medtronic.
This sounds awful, Debra. If your doctor appears to be “dismissing” whatever problems you are still experiencing with your ICD, please get a second opinion. Best of luck to you…
I had my ICD implanted in 2002, had a number of years of no shocks and then in 2011 all hell broke loose. I stared having regular shocks and my sanity went with it. Things got so bad for me that they replaced it in 2013 and cross my fingers, I have had no shocks since…but I am a nervous wreck and some days find it hard to cope…have a wonderful family and I am slowly getting there. It is amazing to me that this thing has made my life hell, but wouldn’t be without it… Crazy crazy crazy.
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Oh Karen. I’m so sorry all of this happened to you. That’s the unique irony of carrying an implantable device like an ICD inside you – patients trust that it will be there when absolutely needed, yet living with the anticipation can be so stressful! If doctors truly appreciated the depth of this stress, they would be making sure all ICD patients were referred for professional counselling to help them manage these fears. You should not be describing your life as a “wreck” or “hell” – please make an appointment for some talk therapy to help you get through this. Best of luck to you…
Did you talk to an attorney?
I just had my recalled lead removed which was implanted in 2006. Luckily I have great heart care physicians. Everything went well. Now waiting on the bills to come in? I believe St. Jude should be responsible. I have calls into the insurance company but everyone knows that as long as they get paid they don’t care. I feel relief in my chest already just writing this. Thanks for letting me vent some. Best wishes to all heart care patients!
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Hi Randy – if my car were recalled due to concerns over a faulty door lock or airbag or carburetor, you can bet that all I’d ever have to do is return it to the dealer for immediate replacement of the defective part at absolutely no cost to me (other than the inconvenience of arranging for the service appointment). So why wouldn’t St. Jude be expected to be 100% responsible for replacements of their recalled ICD leads – given that innocent parties like you have to undergo not just inconvenience but needless worry and now invasive surgical procedures!?! Why should you or your insurance company have to pay one penny for St. Jude’s recall?
Great take on this story — thanks.
Excellent post. Thank you.
This article is quite eye-opening.
I do not have a Riata lead in my chest but I do have St. Jude device and did have to have a lead revision because of overstimulation of the diaphragm. I remember my initial cardiologist telling me that I would just have to live with it. “Live with it?” Seriously?
Being new to all this, and heart disease, I felt this was the way it was. Then, of course, I found another cardiologist who told me that “No”, if in fact I needed to have therapy delivered with my device that it might be Null and void because of the overstimulation would cancel it out and my persistent PVCs. I underwent an ablation for the PVCs and then the lead revision. Two surgeries in one month.
I’m not sure that the lead was placed improperly but I do believe that the arrogance of my doctor saying that I would just have to live with it was a bit much. Doctors definitely need to be more in touch with their patients.
Doctors and patients working together is the way it should be. After all, it is our bodies and our lives that we place in their hands.
Hi Lucy and thanks for sharing your perspective. That “you’ll just have to live with it” comment is interesting: while it’s true that sometimes in medicine, after ALL possible care options are exhausted, we patients sometimes DO have to accept that we’ll just have to live with a distressing reality, some docs offer that type of dismissive response way too early in the game. Glad you found cardiologist #2; hope you are doing much better now.