Trauma associated with recalls of implanted devices

posted on:
August 14, 2006

author:
Delthia Ricks

Six years ago, Michele Mayer, then 39, went into cardiac arrest at work. Her life was in the hands of her co-workers.

Fortunately, Mayer, who at the time worked in Atlanta as the office manager of a large medical practice, was surrounded by co-workers who knew what to do. Two physicians, cancer specialists, performed CPR for 20 minutes.

“Once the ambulance arrived, they fired up the defibrillator and started to shock me,” said Mayer who now lives in Centerport. “I believe they got a faint heartbeat and took me straight into the ER. The doctors were not sure if I would make it through the night.”

Mayer, a fitness enthusiast, was stunned by a diagnosis of sudden death syndrome, meaning her heart is prone to sudden arrest. She was outfitted with an implantable cardioverter-defibrillator, which she must depend on for the rest of her life to jolt her heart into a proper rhythm.

But Mayer’s emotional trauma didn’t end there. She, like thousands of people worldwide who have an implanted defibrillator or cardiac pacemaker, have had to weather the news of dozens of product recalls.

“I have had to have three replaced because of recalls and one replaced because it didn’t work appropriately, so that’s probably worse than a recall,” Mayer said.

Within the past 18 months alone, Food and Drug Administration recall notices have targeted more than 300,000 implantable heart devices, a majority from Guidant Corp., acquired earlier this year by Boston Scientific.

“These patients are very, very vulnerable — emotionally and physically,” said Carol Patrick, a nurse practitioner at Huntington Hospital, who leads a newly formed support group for patients with implanted heart devices.

William Maisel, director of pacemaker and defibrillator services at Beth Israel Deaconness Medical Center in Boston, shares that perception.

“There is one thing the statistics simply cannot weigh into, and that’s the psychological trauma of a patient walking around with a device that has been recalled. I am not sure how you measure that. I don’t think anyone knows how to measure that,” Maisel said.

Problems with devices have ranged from minor flaws to premature battery depletion. In one instance, a malfunction allowed moisture to seep into the device.

Not all recalled devices require removal, Maisel added. But he underscored that patients often find any recall disturbing and may demand the device be removed. This can pave the way to other problems, such as infection.

Michael Parente, 67, had to have his Guidant pacemaker removed last year. The Holtsville resident said he was informed about the recall in a letter. “It seems that model was leaking at the seams and was causing heart attacks and strokes. My doctor said it had to come out.”

Maisel, who has served as an outside expert, chairing the FDA’s circulatory device panel, said patients need exquisitely functioning medical devices. There is no room for error. He added that companies also need to be far more cognizant of the emotional trauma — and deaths — caused by poorly manufactured products.

A recall last year of a Guidant defibrillator was prompted by at least two deaths.

“I am disappointed with the way Guidant handled these recalls,” said Dr. Paul Maccaro, director of arrhythmia services at Huntington Hospital. “When I feel that way, it’s hard to hide that from the patient, and I don’t think it’s right to hide anything from the patient because it is my responsibility to make certain that they’re aware of the risks of the devices and the benefits of the devices.”

Maccaro emphasized that patients in need of a cardiac device should not shy away from one. Clinical trials have repeatedly demonstrated, he said, that such patients have a 1 in 5 chance of cardiac arrest, compared with 1 chance in 1,000 of having a flawed device.

In October, the Heart Rhythm Society, the professional group of doctors who implant pacemakers and defibrillators, is expected to issue the nation’s first guidelines, governing how patients and doctors are to be informed about recalls. The rules also call for an independent panel to monitor manufacturing processes.

Annette Ruzicka, spokeswoman for Boston Scientific/Guidant, said her company fully supports oversight from an outside panel. She added that patients and doctors are now routinely updated about the implants.

Rob Clark, spokesman for Medtronic, said his company also supports the guidelines. Clark estimated that between May 2005 and April of this year, recalls affected 87,000 of his company’s devices worldwide.

Heart of the matter

An implantable cardioverter defibrillator monitors heart rhythms, delivering shocks if dangerous rhythms are detected. Recent recalls have affected tens of thousands of heart patients worldwide.

How defibrillators work

1 Like a pacemaker, an ICD consists of a battery and an electrical circuit, known as a pulse generator, connected to one or more insulated wires.

2 Pulse generator and batteries are sealed together and implanted under the skin, usually near the shoulder. Wires are threaded through blood vessels from the ICD to the heart muscle.

3 ICD continuously monitors the heart rate. When a rapid or irregular heartbeat is detected, the ICD delivers a shock that resets the heart to a more normal rate.

Some recent recalls

JUNE2005

Guidant announces a recall of 37,000 defibrillators due to faulty wiring

NOVEMBER 2005

Medtronic Inc. announces recall of about 41,000 pacemakers due to a wiring problem.

JUNE

Boston Scientific, after acquiring defibrillator manufacturer Guidant, recalls nearly 23,000 defibrillators and pacemakers.

SOURCES: U.S FOOD AND DRUG ADMINISTRATION

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