Medical Device Daily Associate

Implantable device powerhouse Medtronic (Minneapolis) reported the release of the 2006 Medtronic CRM Product Performance Report (First Edition, Volume 54), incorporating up-to-date information about pacemaker, implantable cardioverter-defibrillator (ICD) and implantable lead performance.

The 177-page report – available at and also distributed to more than 27,000 physicians – comes at a time when companies in the cardiac rhythm management field are attempting to come to grips with a slew of problems with their products, with those by competitorGuidant (Indianapolis) being the most visible.

Since June, Guidant has issued recalls or safety advisories for 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the devices.

Data contained in Medtronic's 2006 report are generated from analysis of returned products and postmarket studies and are applicable to the more than 6.6 million total implanted devices and more than 3.4 million currently implanted (active) devices in the U.S., the company said.

According to company spokesperson Kyra Schmitt, while the company has been doing these kinds of reports for more than 20 years (dating back to 1983), some changes were made for this year's version. These, she said, could be linked to the industry's desire to standardize how this type of data is presented.

One new change the company made, she told Medical Device Daily, was to break down product survivals into two categories: malfunction-free survival and all-cause survival. Malfunction-free survival represents “the probability for a device to survive without malfunction,“ excluding normal battery depletion. All-cause survival represents the probability for a device “to survive a period of time without malfunction and without normal battery depletion. For example, if a device survival probability is 95% after five years of service, then the device has a 5% chance of being removed due to normal battery depletion or malfunction.“

The survival estimates are based primarily on “return product analysis,“ according to the report, an approach it terms “suitable because a significant number or explanted generators are returned for analysis.“

Noting that that “[a]ll product performance reports are not created equal,“ Medtronic asserts that it is the only company to use both returned product analysis and also multi-center clinical studies to monitor performance.

Schmitt said that the report also contains a four-page product advisory update that breaks out information on several recent recalls of certain Marquis pacemakers and Sigma ICD and CRT-D devices.

“I think many of the changes that we instituted that I just outlined are based on feedback that we have received in current efforts for the whole industry in terms of standardizing our reporting,“ Schmitt told Medical Device Daily.

The report states that for the past several months, Medtronic CRM has been helping to lead an effort by an industry working group to develop requirements for uniform product performance reporting.

“The goal of this effort,“ the report said, “is to have product performance reports provide the most objective, feasible representation of device performance and to make comparisons across different manufacturers practical.“

Schmitt said another thing that distinguishes Medtronic from its competitors is that it includes lead performance data in its report instead of providing survival estimates based solely on returned product analysis.

The company's lead survival estimates include both lead hardware failure and lead-related medical complications.

“If you ask certain healthcare professionals what is the kind of data that they need, I think that's a big part of it, because that system does not work without a lead,“ said Schmitt.

The company also said the report provides a new, easy-to-use format organized by product family and model number. Data on each model is presented in one place with links provided when additional details are available.

The new report provides extended malfunction listings to include the number of malfunctions that have affected the generator's ability to deliver therapy. This provides a perspective on how often a malfunction may have the potential for more serious clinical impact, the company said.

Additionally, an expanded discussion of the methods and assumptions used to determine survival estimates is provided. This, the company said, enables comparison of Medtronic's performance results with those published by others in the industry.

“For every patient, the quality of their device means everything,“ said Steve Mahle, executive vice president of Medtronic and president of Medtronic's Cardiac Rhythm Management business, in a statement. “Over the past 20 years, Medtronic has continually improved our performance reports based on physician feedback. Our goal is to provide device performance information in a manner that is forthright, meaningful and useful for patient care.“

Mahle added: “In addition, as a member of the AdvaMed Pacemaker/ICD Working Group, Medtronic will work to improve and standardize industry reporting practices to help physicians and patients better understand the risks and benefits related to CRM products.“

The company said that the CRM Product Performance Report is produced semiannually to provide “timely and reliable information“ on device performance to physicians “so that they can make better treatment decisions for their patients.“

Medtronic said it strongly encourages the return of explanted devices to the company. This, it said, enables further research and device testing which results in “more robust performance data and high-quality products to help people live longer, healthier, more productive lives.“