Guidant Issues Pacemaker Warning
Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made from 1997 to 2000, of which some 28,000 remain implanted in patients worldwide.
The Indianapolis-based company, which last month recalled almost 109,000 defibrillators, released a warning that said a sealing component in the pacemakers had degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.
About 78,000 of the pacemakers were distributed, with about 18,000 remaining in U.S. patients, the company said. The devices, which send electrical pulses to the heart to accelerate a slow heartbeat, have a 7- to 10-year life span before they must be replaced.
Guidant said it had identified 69 failures among the pacemakers -- all after they had been used for at least 44 months. The models are: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.
The company told physicians they should consider replacing the pacemakers for patients who are dependent on the devices.
Several patients implanted with the devices have lost consciousness or developed possible heart failure, Guidant said. It reported the death of one person whose pacemaker might have failed, but it said the role of the device could not be confirmed as it was not returned for testing.
Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant’s warning. The company said the FDA might classify the warning as a recall. Guidant issued two safety warnings last month for 11 models of defibrillators that were later classified by the FDA as recalls.
Defibrillators, three times the size of pacemakers, are also implanted. Almost 88,000 of the Guidant devices that were recalled remain implanted worldwide.
The problem with Guidant’s pacemakers poses less of a risk for patients than that of its defibrillators, said Dr. Angel Leon, chief of cardiology at Emory Crawford Long Hospital in Atlanta. That’s because of the relatively small number of pacemakers implanted and because the degradation that can occur does so gradually, allowing patients more time to seek help.
Guidant said that it would replace the pacemakers at no charge through the end of the year, even though the warranty on many had expired, and that it would reimburse patients as much as $2,500 for medical expenses.
The company, which has faced a barrage of criticism from patients and physicians on its handling of the recalls and warnings, also said in its statement Monday that it planned to set up an “independent panel of experts to recommend guidelines for when to disseminate information” on its devices.
Guidant shares fell $2.10 to $67.31. They have traded in a 52-week range of $49.95 to $75.15.
Those levels compare with a $76-a-share offer from Johnson & Johnson that Guidant shareholders voted to accept in April. The $25.4-billion cash-and-stock deal is pending.
Jeffrey Leebaw, a spokesman for New Brunswick, N.J.-based Johnson & Johnson, said Monday that the company stood by its June 17 statement that it was working to close the acquisition in the third quarter. It called the initial safety advisories “serious matters.”
