Unexpected and inappropriate shocks to the heart

Jackson underwent emergency surgery to replace the defibrillator but continued to have anxiety from the experience. He says he is now at an increased risk of cardiovascular events or death because of the inappropriate shocks to his heart, which is causing him pain, extreme anxiety, fear of death and great physical, emotional and psychological suffering.

Jackson’s case is one of several that have come to light over the years after patients reported experiencing sometimes excruciatingly painful electric shocks in their chest. Certain models of the leads, which connect to the defibrillators, were found to have fractured, causing the defibrillators to unnecessarily shock patients or fail to work altogether. As a result, on October 15, 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator Leads. To date, Medtronic has reported 13 fatalities associated with the faulty leads.

Jackson’s complaint contends that Medtronic did not provide him with notice of the increased fracturing risk and made unconscionable or fraudulent representations regarding the product.

SOURCE: Sprint Fidelis Lead Recall › Texas man suffers from PTSD from defective cardiac defibrillator

As we have reported earlier, a Texas man filed a lawsuit against Medtronic, claiming that his cardioverter defibrillator containing a Sprint Fidelis lead gave him several unexpected and unnecessary shocks, causing excruciating pain and emotional stress.

To ensure that the software update fulfills its purpose and protects patients as it was designed to do, Medtronic will actively monitor the update during actual use.

According to Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, Medtronic’s software update “will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock. While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators deliver a pulse of energy through a thin electronic wire (the lead) whenever it detects a rhythmic abnormality in the heart. The shock sets the heart back into a normal rhythm.

SOURCE: Sprint Fidelis Lead Recall › FDA approves software update for faulty defibrillator

Plaintiff Donald Jackson received an implantable cardioverter defibrillator containing a Sprint Fidelis lead in 2006, which he says gave him unexpected and medically unnecessary shocks, causing excruciating pain.

The shocks caused “great physical, emotional and psychological suffering and extreme anxiety,” placing Jackson in “imminent apprehension of death,” the complaint says. It adds that Jackson is now prescribed mood-stabilizing drugs. And, as a result of problems with the lead, he has an increased risk of death or major heart problems.

The complaint, filed Jan. 18 in the U.S. District Court in the Eastern District of Texas, alleges Medtronic misrepresented the safety of the leads and negligently manufactured, marketed and sold the leads as safe, effective devices. Because such acts were “intentional, reckless and grossly negligent,” the plaintiff is seeking punitive damages.

February 4th, 2008 by Staff with FDA News

SOURCE: Sprint Fidelis Lead Recall › Lead shocks send patient to psychiatrist

His implanted cardiac defibrillator (ICD) had sent 800 volts of electricity into his heart muscle, a jolt doctors compare to being kicked by a horse. Then it did it again. And again.

“I was hollering every time it hit me,” Jackson said. “It hit me six times … it’s a good wallop. I began to think it wasn’t going to stop.”

As their granddaughter screamed, Mattie Jackson called 911. She assumed her husband was suffering from an extreme rapid heartbeat, a life-threatening episode he had experienced twice in 2004.

The ICD was implanted to shock Jackson when his heartbeat speeds out of control. Instead, it seemed to be killing him.

“I was terrified,” said Mrs. Jackson, her eyes watering as she recalled him shrieking in pain.
At the hospital, doctors found that a wire, or “lead,” running from the matchbox-size defibrillator under his collarbone, had broken inside his heart. The two fractured ends had caused a false electrical impulse and triggered the ICD to shock him.

“It was telling the defibrillator something was happening, so it just went shooting out those pulses,” Jackson explained. “It thought something had happened to my heart.”
He was wheeled into emergency surgery the next morning.

“They took me in, cut me open, pulled out the defibrillator, pulled the wire out and put a new wire (and defibrillator) in,” he said.

Despite his surprise at the ordeal, Jackson said his experience wasn’t a fluke.

He and some 235,000 people worldwide received word in October from Medtronic Inc., the world’s largest ICD maker, saying the wire lead threaded into their hearts to deliver shocks at 800 volts a pop was recalled from the market because of its tendency to fracture.

The Sprint Fidelis lead, a newer streamlined wire issued by Medtronic, was fracturing at a rate of 2.3 percent in 30 months, twice the rate of its predecessor.

Medtronic urged patients to visit their cardiologists and have the defibrillators programmed for tighter self-check alerts. Jackson was one of dozens who met with his cardiologist, Dr. Alex Petrakian of Cardiovascular Associates of East Texas.

Petrakian said Medtronic underestimated the faulty wire’s effect, as he noticed problems much earlier than October, and with more frequency. Of his 65 patients implanted with a Sprint Fidelis lead, Jackson was the eighth to present with a fracture.

“We noticed a problem with that wire before they recalled it, so I stopped using it (in July),” Petrakian said. “It was unusual that there were reports from all over the country about docs having the same problems.”

The possibility of a fracture is frightening, he said. While Jackson was shocked six times, others suffering lead fractures have been shocked double or triple that number.

“Sometimes they present to the hospital after having 20 or 30 shocks,” Petrakian said. “Medtronic said those shocks have actually killed; the shocks themselves have caused the heart to stop.”

Complicating the recall is the recommendation that patients with ICDs not have them surgically removed until they malfunction.

“We don’t recommend going in and replacing those wires if they’re not fractured, because of the risk of the procedure itself, risk of infection and other complications,” Petrakian said.

Scar tissue can quickly envelope a lead, which is threaded into one of the heart’s lower right chambers and screwed into the heart muscle, he said.

Instead of invasive remedies, Medtronic is urging closer monitoring of those Sprint Fidelis patients and is footing the bill for the co-pays, procedures and recovery of complications of related fractures, said Medtronic spokesman Rob Clark.

“This is one of the largest actions ever taken,” Clark said. “We did it proactively, so patients who have Fidelis leads could go into a physician and, in most cases, can have the device reprogrammed; any fractures or weakening that develops, they’ll be able to see that in advance so appropriate action can be taken.”

But 64-year-old Athens resident Ruby Barrett said that doesn’t come close to allaying her fears.

Her ICD (and its recalled lead) was implanted just 39 days prior to Medtronic’s announcement. She was sickened by the news of the recall, she said, and feels helpless, like she’s waiting for her ICD to malfunction.

“I hope to God not, but if anything goes wrong in there I’m probably going to die,” said Barrett, who suffers from congestive heart failure. “I don’t want to go out of here being shocked to death.”

ICDs are revolutionary treatment for patients prone to irregular, slow or fast heartbeats that put them at risk for sudden cardiac arrest. Medtronic estimates some 15,000 people have received life-saving shocks since the equipment’s inception.

Petrakian said he and other cardiovascular surgeons implant some 500 to 600 ICDs each year in East Texas. But the wear and tear on leads is great, he said; the heart is a volatile space.

“Leads don’t last forever,” Petrakian said. “With every heartbeat, the lead is moving. It flexes back and forth, and so you can just imagine, flexing back and forth millions of times puts pressure on the lead.”

Clark agreed. The lead’s design, manipulation of the lead during the implantation procedure, the harsh environment of the heart and the patient’s body type can all contribute to the equipment’s viability, he said.

Medtronic, a $12.3 billion company, reported a 16 percent sales drop in its 2007 fiscal second quarter, about a $150 to $200 million loss, Clark estimated.

But Medtronic is no stranger to working out equipment flaws. This month, the company agreed to spend $114 million to settle 2,682 lawsuits related to an earlier line of ICDs that suffered a potential battery shorting problem announced in February 2005.

Petrakian said a handful of his patients are considering legal action after October’s recall, but said most of it is due to anxiety.

“I’d be anxious about it,” he said. “Having a recalled lead, especially if the incidence is that high.”

Mrs. Jackson said she’s just relieved the lead is gone from her husband’s chest. She’s glad to have gotten through it.

“If it wasn’t for our church family, God, prayer,” she said, “I don’t know what we would have done.”

December 27th, 2007 by LAUREN GROVER with Tyler Paper.com

SOURCE: Sprint Fidelis Lead Recall › Recalled heart implant gives man shock of his life