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Phyllis
Medtronic says some pacemakers faulty Tue Nov 29, 5:24 PM ET
Medtronic Inc. said on Tuesday it is advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit.
The Minneapolis-based medical device maker said the overall incidence rate is "extremely low" and there have been no reports of patient injuries or deaths related to the issue.
However, the problem could result in early battery depletion, loss of rate response -- the ability of the device to increase the rate of pacing when the patient is active - or no pacing output, the company said. For patients dependent on pacemakers to maintain an adequate heart rate, loss of pacing output can cause sudden faintness or loss of consciousness.
Medtronic said it has seen the wire separation problem in 19 devices, about 0.05 percent of the subset of pacemakers affected. About 28,000 Sigma pacemakers are subject to the advisory worldwide, with 6,650 of those in the United States, the company said.
The company said it does not recommend replacing the devices, which last about 10 years, prior to normal elective replacement, but encourages patients to consult with their physicians to discuss their individual situations.
Medtronic said it did not anticipate any material financial impact because of the notification.
Morgan Stanley analyst Glenn Reicin, in a note to clients, said he did not expect the notification to result in a U.S. Food and Drug Administration recall of the product. He predicted less than 5 percent of the affected patients would seek replacement of the pacemaker, which is an older-generation model.
"Given that this failure is contained to a specific manufacturing process and a limited number of devices, it is unlikely that additional models will carry this problem," he said.
Reicin said Medtronic likely chose to notify physicians of the problem because the failure rate exceeded the 1-in-1,000 threshold discussed at a meeting this fall of the Heart Rhythm Society, which followed Guidant Corp.'s highly publicized recalls of pacemakers and implantable defibrillators over the summer.
Shares of Medtronic ended down 15 cents Tuesday at $56.14 on the New York Stock Exchange.
Medtronic Inc. said on Tuesday it is advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit.
The Minneapolis-based medical device maker said the overall incidence rate is "extremely low" and there have been no reports of patient injuries or deaths related to the issue.
However, the problem could result in early battery depletion, loss of rate response -- the ability of the device to increase the rate of pacing when the patient is active - or no pacing output, the company said. For patients dependent on pacemakers to maintain an adequate heart rate, loss of pacing output can cause sudden faintness or loss of consciousness.
Medtronic said it has seen the wire separation problem in 19 devices, about 0.05 percent of the subset of pacemakers affected. About 28,000 Sigma pacemakers are subject to the advisory worldwide, with 6,650 of those in the United States, the company said.
The company said it does not recommend replacing the devices, which last about 10 years, prior to normal elective replacement, but encourages patients to consult with their physicians to discuss their individual situations.
Medtronic said it did not anticipate any material financial impact because of the notification.
Morgan Stanley analyst Glenn Reicin, in a note to clients, said he did not expect the notification to result in a U.S. Food and Drug Administration recall of the product. He predicted less than 5 percent of the affected patients would seek replacement of the pacemaker, which is an older-generation model.
"Given that this failure is contained to a specific manufacturing process and a limited number of devices, it is unlikely that additional models will carry this problem," he said.
Reicin said Medtronic likely chose to notify physicians of the problem because the failure rate exceeded the 1-in-1,000 threshold discussed at a meeting this fall of the Heart Rhythm Society, which followed Guidant Corp.'s highly publicized recalls of pacemakers and implantable defibrillators over the summer.
Shares of Medtronic ended down 15 cents Tuesday at $56.14 on the New York Stock Exchange.
