A faulty heart pacemaker wire has been blamed for two deaths, prompting a meeting between federal regulators and the manufacturer concerning 40,500 people worldwide who have the device in their chests. Food and Drug Administration officials and executives from Telectronics Pacing Systems Inc. in Englewood, Colo., will try to determine whether surgery would be more risky than leaving the devices intact. "We're concerned," Bruce Burlington of the FDA said Thursday. "The really hard question is, do you tell people to undergo the surgery to have these wires replaced?" Telectronics got wind of a problem in October when a woman who had received the pacemaker died after the connecting wire poked through its insulation. Upon investigation, the company discovered another, similar death two years earlier and 11 other incidents in which patients had similar problems but recovered. The wire--known as a J-lead because of its shape--has been used since 1987. In November, Telectronics sent a warning letter to 7,000 doctors known to have patients with the wire and set up a toll-free number: (800) 349-9446. The company also recalled 1,500 unused J-leads, but it made no public announcement of the situation.
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