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Some Heart Patients with St. Jude Battery are Ticked Off

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Modesto, CA: As if it isn’t bad enough that St Jude Medical allegedly failed to properly report the risk of early battery-depletion and two deaths that finally led to a recall, some heart patients were never informed of the recall. And now, knowing that your defibrillator could fail at any time exacerbates problems that heart patients are already dealing with, from risk of infection to emotional and financial issues.

Emotionally Draining

Gene’s wife has a recalled ICD. He says she gets “a little dizzy at times when her chest hurts but we don't know if it's the ICD causing it. The real injury is how much she worries about the ICD problem. My wife suffers from anxiety and depression, and PTSD from past things that have happened to her. She takes medication for all three problems. Now she is suffering an emotional injury from this recall.”

Risk of Infection

Having a pacemaker implanted is one of the most common types of heart surgery, but placing the batteries in pacemakers and cardioverter defibrillators exposes patients “to a risk of serious complications, including life-threatening infection”, wrote two consultant cardiologists in an article published in the British Medical Journal (February 4, 2016). John Dean and Neil Sulke also said that, “Over half of all patients with pacemakers require a replacement procedure because the batteries have reached their expected life.” But patients with a St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device may have batteries that fail earlier than expected. They went on to say that, “The situation is worse for recipients of a (cardioverter defibrillator), since the risks of infection at the time of implant and device replacement are higher than with pacemakers and the batteries have a shorter life.”

Changing the batteries involves replacing the pacemaker box with a new unit, which is typically performed under local anesthetic via a cut to the skin. But hospital infections have increased faster than pacemaker implantation. According to a study published in The Journal of the American College of Cardiology, the number of cardiac devices being implanted has doubled since 1993 and the number of associated infections has more than tripled. This is likely because cardiac patients are more vulnerable to infection because they tend to be sicker in the first place.

“Mentally I'm not the same since my defibrillator leads became infected and needed risky surgery that almost killed me,” writes Ian from Nova Scotia. “I’m afraid of swimming, afraid to pick up my kids and I’m afraid to drive. It has affected much of my daily life, not to mention time lost during recovery and the torment it caused my family and children to watch helplessly as their father shakes and cries on the ground for the shocks to stop.”
“I got a call from my doctor, telling me that I need to get my ICD replaced,” says Janet, “but I’m deathly afraid of stepping foot into a hospital. I know it’s not major surgery, but infections are rampant and I’m not in the best health, which means I’m a prime candidate for infection. And if I get sick, who pays for my hospital stay and antibiotics?”

Good question. And who pays for the battery replacement?

Financial Concerns

“I don’t feel comfortable knowing that my defibrillator could fail at any time,” says Gene in Seattle. “St Jude should pay for the replacement, and they should compensate me for the daily anxiety of the possible consequences! But I suppose they are off the hook until my device fails. I’m ticked off, to say the least.”

In October, 2016 the FDA and St. Jude Medical said they were alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Bill, writing from Modesto, California, says he was never notified, despite the leads in his pacemaker being on the recall list. “My pacemaker had a dead battery for about a year. As if that isn’t bad enough, I had to pay full price for a replacement, no rebate or refund.” He is hopeful that by joining a lawsuit he can get some kind of compensation.


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want some to help me get help for my husband I believe that I'd kill him

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This Recalled St Jude Medical ICD is the second ICD implanted. The first, Medtronic, was also recalled. None of my doctors, ICD surgeon, allowed a real informed consent. They said what they wanted to sell the devise, then shoved a paper in my face to sign, but did not have time for me to read it, "The surgeon is waiting!" Neither the cardiologist, the pacemaker surgeon or the manufacturing companies ever bothered to let know about this faulty, unacceptable piece of machinery that is implanted in my body, and has been recalled!! I found out accidentally on the internet! I don't even know how to properly express my disgust with St Jude Medical, Abbott Laboratories, the doctors that deceived me and betrayed me. At this point I am disgusted with the broken medical system, that cares about money much more than it cares about humans. I remember when my cardiologist said it would be" like having an Angel on your shoulder to protect me" Instead these devices "are like having having a demon implanted into my body. And my body, my mind, and soul, want it exorcised from my body STAT!" I have been told that I am not allowed to review the written consent form, I was told that my lawyer (what lawyer?) would have to request it!

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I learned about the recall on the 5:30 news cast in early Oct 2016, never got any letter from St Jude or the EP Doctor. I called and, got a visit with the doctor to be told St Jude will pay all the bills incurred, I had to pay for that visit. Dr Whitehill replace the ICD on December 2, 2016. and to this day St Jude has not paid any of the bills. I have called. texted, left messages, wrote a letter. Now I get letter and calls from collection agency. St Jude ignores me ~ I am retired on Social Security

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The cardiology practice I use elected to replace all St. Jude ICD's in patients who were "pacer dependant". This is in addition to receiving a free wireless monitor. While the hospital initially charged for the replacement unit, Medicare came back 6 months later and reversed the charge, which was close to $100K.


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