Exposed Nerve

Cyberonics has implanted its pacemaker in thousands of epileptics. It wants to expand to the depression market. Still needed: an accounting of those who died or were injured after receiving its implant.

We may have a problem.

X-rays showed that Laurent had inverted the wires connecting to Sam's vagus nerve, just as he had in at least 74 other children, according to a class-action lawsuit filed in Harris County District Court in 2003. (The Goldsmiths are not part of the suit.)

But the news wasn't entirely bad. According to the Goldsmiths, Wilfong said that the device was still working properly and wouldn't need to be replaced.

Dave Goldsmith settles Sam into bed every night.
Daniel Kramer
Dave Goldsmith settles Sam into bed every night.
Cyberonics hopes to use VNS for Alzheimer's, obesity and migraines.
Courtesy of Cyberonics
Cyberonics hopes to use VNS for Alzheimer's, obesity and migraines.

By the end of 2003, it looked like Sam had fallen into the category of patients who were neither harmed nor helped by the therapy. Wilfong suggested brain surgery -- a procedure that has helped many treatment-resistant epileptics like Sam. So in January 2004, surgeons at Texas Children's spent ten hours carving out a chunk of the boy's temporal lobe.

The surgery was a disappointment. Sam continued to seize and, a few months after the operation, wound up in Memorial Hermann Hospital during a grand-mal. According to the Goldsmiths, the doctors turned off Sam's pacemaker in order to conduct an MRI. With a subsequent X-ray, doctors saw the device was inverted, and they refused to turn it back on. They did not know how inverted wires were affecting Sam, the Goldsmiths say.

"That raised a whole lot of red flags for me and Monika," Dave Goldsmith says.

The device remained off for two months, and the Goldsmiths saw no difference in their son. It was clear: The $15,000 bundle of titanium and wires in Sam's body was not worth a cent.

The Goldsmiths returned to Wilfong and demanded he refer them to a surgeon who could implant a new pacemaker correctly. After a successful replacement, the Goldsmiths noticed a moderate reduction in Sam's seizures.

Laurent died in his River Oaks home in November 2004. The class-action suit's remaining defendants are Wilfong and Cyberonics. Wilfong declined to comment for this story.

Cyberonics spokesperson Liza Heapes says Laurent received the company's standard "surgical training kit," which includes an instructional book and video and a dummy pacemaker for practice. Using this training kit, surgeons have implanted devices in 30,000 adults and children around the world. Thousands have had to be removed and/or replaced, and the company has not told the FDA why.

In the Goldsmiths' case, the explanation is clear: A renowned neurologist referred them to a gifted surgeon who, with manufacturer training, botched what the company calls a "straightforward" procedure.

"I think what putting the first VNS in incorrectly took from us," Dave Goldsmith says, "was a whole year and a half or almost two years…of it not doing as much as it could've done for us, at the very least. And possibly harming him in some way."

First of all, if you're talking to Cyberonics, don't call it a pacemaker. That word rarely appears in company literature.

They prefer Pulse Generator. The Pulse Generator provides the trademarked Vagus Nerve Stimulation Therapy, named after the nerve whose Latin name means "wandering." The vagus nerve wanders from the brain stem through the neck, thorax and abdomen.

About the size and shape of a silver dollar, the pacemaker is implanted below the left collarbone, and two wires are attached to the vagus nerve. Cyberonics' patient's manual lists a total of nine side effects, including skin irritation, blood clotting, paralysis of nearby nerves and muscles, and changes in heart rate. The physician's manual lists 49 side effects, including device migration, insomnia, gastric ulcers and formation of fibrous tissue. And, unlike the patient's manual, the physician's manual explains that the electrical leads can in fact paralyze the nerve they're supposed to stimulate.

Cyberonics describes implantation as a simple procedure taking between 30 and 90 minutes. In most patients, the pacemaker stimulates the left vagus nerve for 30 seconds, stops for five minutes, then turns back on for another 30 seconds. Patients who feel a seizure coming on, or are already in the midst of one, can use a magnet to automatically activate the device. The FDA in 1997 approved it for people more than 12 years old who suffered from treatment-resistant epilepsy. These were the unfortunate patients who had exhausted every pill, diet and surgical alternative. Although the FDA does not approve it in younger patients, off-label use -- implanting the device in kids under 12 -- is legal and common. However, Cyberonics' policy lists any adverse event in off-label use as "user error." Meaning that, technically, if Sam's device were to spontaneously combust, it would be the Goldsmiths' fault.

With FDA approval, Cyberonics grew from an office in a League City strip mall to a marble-floored HQ in Clear Lake. According to the company's 2004 annual report, Cyberonics' fiscal 2004 net income was $6.8 million, with worldwide net sales at $110.7 million. About 350 of the company's 550 employees live in Houston.

Although the company always aimed for the treatment-resistant-epilepsy market, doctors grew curious when some patients reported elevated moods.

The company launched clinical trials for depression in 1998, and before the trials were over, Cummins issued press releases touting the therapy's success. By 2001, Europe and Canada had approved the device for treatment of depression. However, the company knew that widespread use would be impossible without FDA approval. Thus began the story of Cyberonics v. FDA, with Skip Cummins emerging as the company's most outspoken officer.

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