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?
READ MORE ST JUDE CARDIAC DEFIBRILLATORS LEGAL NEWS
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.