Medical Device Daily

Guidant (Indianapolis) in April succeeded in negotiating the rugged acquisition waters and was purchased byBoston Scientific (Natick, Massachusetts). But that by no means brought an end to turbulence on the technology side of things.

Early yesterday, Boston Scientific reported that it is providing what it termed “safety information” and recalling – though it termed this “retrieving” – a “subset” of im-plantable cardiac devices made by its Cardiac Rhythm Management (CRM) business, formerly Guidant.

The notification and recalls are forced by the company's identification of electrical problems in two of its pacemakers, the Insignia and the Nexus; in one of its resynchronization pacemakers, the Contak Renewal TR/TR2; and three of its implantable cardioverter defibrillators (ICDs), the Ventak Prizm 2, Vitality and Vitality 2 ICDs.

The 23,000 devices recalled now add to the total of about 110,000 devices recalled by Guidant over the past year and a half, plus warnings concerning thousands of other devices.

Boston Scientific said that the failures have not resulted in any deaths.

Overall, the warnings reportedly appear to impact more than 27,000 patients implanted with the devices, and a total of 23,000 unused devices are being recalled.

The company said that patients with the affected pacemakers might experience “intermittent or permanent loss of output or telemetry or premature battery depletion.” Patients with affected defibrillators may experience “inappropriate sensing or premature battery depletion.”

To date, a total of five confirmed events have been reported out of about 27,200 implanted devices.

It said there have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output. One event was “a device malfunction discovered at the time of implant,” it said. The other four events involved devices that were implanted and then had to be replaced.

In the wake of the recall announcement, the company's shares fell about 6% to $17.16 in trading at mid-day and fell further to $17.06 at yesterday's close.

According to Boston Scientific CRM, the problem involved a supplier's low-voltage capacitor – a component for electrical charge storage – not performing to expectations. Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. The company is not recommending any explants of the devices identified in the safety notice.

Some analysts indicated that given the pinpointing of a supplier as the source of the problem, other similar problems in this area might be uncovered further out.

This possibility also was suggested by Boston Sci CEO Jim Tobin, who in a morning conference call said that the company is reviewing all of the systems provided by suppliers and acknowledged the presence of “deeper issues.”

While not specifying the dates that the devices were manufactured, he said that the problems had occurred in “batch after batch and now we're paying the price.” He added that it could take up to two years to resolve all of the engineering problems identified or yet to be uncovered.

The company said that an engineering analysis is ongoing and that it will further communicate on this issue when it has more information.

The company is asking implanting and following physicians to schedule an in-clinic follow-up visit “as soon as possible” for all patients with implanted devices from this subset to assess device function. The follow-up visit is to look for “behaviors,” it said, that may indicate capacitor malfunction such as premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements.

In a company statement announcing the alert and recalls, Tobin said that the notification “reflects Boston Scientific's industry-leading commitment to implementing recommendations made by both the Heart Rhythm Society [Washington] and the Independent Panel Commission chaired by Dr. Robert Myerberg.”

He added that Boston Scientific is “the only CRM company that has committed to implementing these recommendations, which it believes are in the best interest of patients and physicians.”

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