SAFETY ADVISORY Guidant issues warning for 28,000 pacemakers
The company said it has identified 69 failures among the devices.
INDIANAPOLIS (AP) -- Guidant Corp., already under fire for problems with its implantable defibrillators, on Monday warned physicians replacements might be needed for nine pacemaker models made between 1997 and 2000.
The safety advisory, which affects 28,000 devices in use worldwide, heightened concerns among heart patients and raised new questions about the wisdom of a planned $25.4 billion acquisition of Guidant by New Brunswick, N.J.-based Johnson & amp; Johnson.
"They have a lot of trouble to fix. Guidant has killed their name," said Lisa Salberg, president and founder of the Hypertrophic Cardiomyopathy Association, a patient advocacy group. "There's going to be a lack of trust."
The Indianapolis-based company said a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.
Guidant distributed about 78,000 pacemakers, about 18,000 of which are still in use in U.S. patients. The devices, which send electrical pulses to the heart to accelerate a slow heartbeat, have a seven- to 10-year life span before they must be replaced.
The company said it has identified 69 failures among the pacemakers -- all after they had been used for at least 44 months. The models include: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.
Several patients have lost consciousness or developed possible heart failure, the company said. The statement reported the death of one person whose pacemaker may have failed, but Guidant said the device was not returned for testing and its role could not be confirmed.
The company said it would replace the devices, which are about the size of two half dollars held together, at no charge through the end of the year, even though the warranty on many has expired. Guidant also will reimburse patients up to $2,500 for medical expenses. Pacemakers are implanted during a short surgery when an incision is made near the shoulder.
Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. Guidant said the FDA might classify the warning as a recall.