The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.

Medtronic’s new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

“One concern is that the use of ICD therapy could trade a quick, relatively painless (albeit premature) death for a more unpleasant death from progressive deterioration of the underlying heart disease or a coexisting illness,” the researchers wrote.

The study, led by Dr. Daniel Mark of Duke University Medical Center in Durham, North Carolina, used quality-of-life tests to assess the psychological well-being of 833 volunteers who received standard medical care, 830 who got additional drug treatment with amiodarone, also known by the Wyeth-Ayerst Pharmaceuticals brand name Cordarone, and 816 who received Medtronic ICDs.

Another study from the same trial, also published in the Journal, found that ICDs seem to provide short-term comfort for patients during the first year, although the psychological benefit disappeared at the 30-month mark.

Implantable cardioverter-defibrillators or ICDs, are known to reduce the risk of death. In the study that served as the basis of the new findings, Medtronic ICDs reduced the death rate by 23 percent over nearly four years.

The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries, according to reports filed with the agency, the Journal reports.

The FDA’s alert about Infuse was specific to neck surgeries. But a review of FDA records and medical literature shows there have been scores of other cases in which serious complications arose after the product was used in other off-label situations. Many of these cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.

Three “whistleblower” lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company, the Journal reports. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing.

One of the whistleblowers has challenged the company’s agreement with the federal government, saying the sum is too small. The lawsuit that hasn’t been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.

The study followed about 1,800 patients faced with the prospect of either bypass surgery to unclog an artery, or to implant a stent to open it.

After one year, of those who received bypass surgery 12.1 percent died. Those who received a stent did not fair as well, experiencing a 17.8 percent mortality rate.

Bypass surgery also lessens the frequency of repeat surgeries, where as stents put patients under the knife at least twice as much.

According to the study results, only 5.9 percent of bypass patients required a follow-up corrective surgery within 10 years. That figure is dwarfed by the 13.7 percent of stent patients who needed another surgery in less than 10 years.

That figure is low but the revision rates were higher for people who had new surgical techniques called hip resurfacing and unicondylar knee replacements, a finding the researchers said raises concern about the procedures.

“On the basis of our data, consideration should be given to using hip resurfacing only in male patients and unicondylar knee replacement in elderly patients,” Jan van der Meulen of the London School of Hygiene and Tropical Medicine and colleagues wrote.

The researchers analyzed nearly 170,000 procedures carried out between 2003 and 2006 — about half of all such surgeries performed in England in this period — and found an overall revision rate of 1.4 percent, or about one in 75 people. Yet hip resurfacing — a newer technique in which doctors replace just the surface of the femur instead of the whole joint — had a revision rate of 2.6 percent, the study found. Unicondylar knee replacement when doctors only replace one side of the knee joint had a revision rate of 2.8 percent.

Hip and knee replacements are some of the most frequently performed surgeries, and medical device makers like Britain’s Smith & Nephew and U.S.-based Stryker Corp have looked to new techniques to profit from an aging population.

Devices already listed include implantable pacemaker pulse generators, replacement heart valves (mechanical only) and automatic implantable cardioverter/defibrillators. Devices used outside a device-user facility that require tracking include breathing frequency monitors, continuous ventilators, ventricular bypass (assist) devices and DC defibrillators and paddles.

The FDA can add or remove devices from the list based on statutory requirements or additional guidance factors, the guidance says.

DC defibrillators and implants have specific tracking requirements. Defibrillators must be tracked to the vehicle, craft or organization that purchased the device, but the tracking does not need to be extended to the patient level. Implants must be tracked to the patient level and updated as necessary. If a patient refuses to have a device tracked, a manufacturer is still required to track the device using the product model and serial number.

“We understand why the court would make that ruling, but what the plaintiffs are claiming is not true, and we will be able to prove that is not true,” Jeff Goldberg, Advanced Bionics senior vice president of regulatory affairs, said.

Goldberg said the parents’ allegations stem from an administrative claim filed against Advanced Bionics by the FDA last November. The claim, which was amended in March, accused the company of using components from an unapproved supplier. The company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, agreed to pay a $75,000 fine. Initially, the FDA had sought a $1.1 million fine from him in addition to the company’s fine.

“But that suit was settled without us ever admitting any liability,” Goldberg said.

According to the district court order, the Purcels’ suit centers around a single component of the HiRes90k — a feed-thru manufactured by Astro Seal — that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.

In a release, the FDA says it is in the beginning stages of creating a database of these controversial medical devices. Joints like artificial hips and knees have been linked to injuries and post-operative failures, often requiring additional corrective surgeries.

If the FDA demanded more disclosure from the companies making these questionable devices they’d already have this list compiled.

Once it’s complete, the FDA would like to have a comprehensive list of medical devices and any formal complaints logged against it and its manufacturer.

Also hampering the effort the FDA can put toward this registry is its budget restraints. It already has a difficult to impossible time inspecting the facilities making the devices, and there is a chance it doesn’t even know all that exist, as was the case with the Chinese facility charged with making the active ingredient in the blood thinner, heparin.

The FDA should create this registry, but to rely on anything but third-party information which is destined to be skewed or unreliable, will open this registry to constant criticisms rather than it serving as an important resource.

Richard and Holly McCullough, owners of Intermedics-McCullough, believe payments totaling more than $8 million were attempts to persuade physicians into buying directly from the manufacturer and not do business with its company, specifically.

The lawsuit alleges Zimmer Inc. and Zimmer Holdings Inc., DuPuy Orthopedics, Biomet Inc., Smith and Nephew Inc., Stryker Orthopedics and Stryker Inc. all made illegal payments to physicians.

The medical device industry, specifically manufacturers of joint replacement parts, has come under fire for paying physicians almost exclusively undisclosed amounts of money as “consultant fees” to endorse one company’s products over another.

The McCullough’s further allege their company is given more expensive and inferior products to distribute.

Specifically under fire are the following payments made to physicians:

> $8.07M from Zimmer to Dr. Harry Rubash, chief of orthopedic surgery at Mass. General Hospital.
> $825k in “royalty income” from Stryker to Dr. James D’Antonio.
> $408k from Zimmer to Dr. Anthony DiGoia.
> $300k from DuPuy to Dr. Lawrence Crossett.

Many of these medical device companies were under federal investigation earlier this year for these kickback payments. Stryker avoided prosecution by participating in the probe.

The Justice Department has since said many physicians accepting the payments were within their rights to accept the payments as they offered professional services in return.