July 18, 2005 at 3:58 PM
Guidant Corp. said Monday it has advised doctors that about 28,000 of its older-generation pacemakers may malfunction and need to be replaced in some patients. The Indianapolis-based company, already beset with a series of recent recalls of heart defibrillators, said the pacemakers affected by the latest announcement have not been sold or implanted for the last four years.
Still, the average lifespan of the devices is 5.75 years and 28,000 of them remain in patients worldwide.
The company, whose Cardiac Rhythm Management Division is based in Arden Hills, said a sealing component used in some of the affected pacemakers may gradually degrade, resulting in higher-than-normal moisture content within the device. The affected models include: Pulsar Max; Pulsar; Discovery; Meridian; Pulsar Max II; Discovery II; Virtus Plus II; Intelis II and Contak TR. The devices were made between Nov. 25, 1997 and Oct. 26 2000.
As of July 11, the company had identified 69 of the devices that may have failed. No failures were reported before 44 months of service, although Guidant said the likelihood of failure increases as the device ages.
The company said if the device fails, it could result in "serious health complications." Twenty reports of pacemakers that didn't properly pace the heart have been associated with the problem.
Additionally, Guidant has received two reports of Maximum Sensor Rate pacing, in which heart failure may have developed in association with high-rate beating of the heart. One patient who experienced this outcome was admitted to the hospital with multiple heath issues and later died, although it is unclear what role the device played in the death.
Guidant will provide a replacement device at no charge for pacemaker-dependent patients. The company will also reimburse patients up to $2,500 for medical expenses remaining after Medicare and private health insurance coverage.
Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. The company said the FDA may classify the warning as a recall. The company issued two safety warnings last month for 11 models of defibrillators that were later classified by the FDA as recalls. Defibrillators, which also are implanted devices, shock the heart back into rhythm. Almost 88,000 of the defibrillators that were recalled remain implanted in patients. In April, Guidant shareholders voted to accept an offer from Johnson & Johnson of $76 per share in cash and stock in a $24.5 billion deal that is still pending. A.G. Edwards & Sons analyst Jan David Wald told the Dow Jones New Service that Guidant's newest warning follows continued internal scrutiny about potential malfunctions in its products."I think it's a company going through their files," he said. "They've gone through their defibrillator product line. Now they're going through their pacemaker product line." Wald said he did not believe Monday's announcement would jeopardize the Johnson & Johnson deal. Guidan't second-quarter earnings are to be released Thursday.
