Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SATURDAY, January 21, 1995 TAG: 9501230065
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: Associated Press
DATELINE: LENGTH: Medium
The overwhelming concern is that more people will suddenly die. But experts are uncertain how best to prevent this, because replacing wires may be riskier than leaving them in.
At issue is the Accufix atrial ``J'' pacemaker lead, models 701 and 801, made by Telectronics Pacing Systems Inc. of Englewood, Colo. The wire is the electrical cable that delivers impulses to the heart to keep it beating regularly.
Telectronics' variety has been among the most popular since its introduction in 1987.
The J-shaped end attaches to the heart like a fish hook. Inside its polyurethane insulation is a coiled electrical wire, plus a 31/2-inch flat wire that helps the lead wire keep its shape.
When this piece of flat wire is bent back and forth, as may happen when people move about, it can break. Then the jagged end may work its way through the plastic. At the worst, it may then poke through the heart and jab the aorta, causing catastrophic bleeding.
So far, Telectronics knows of four instances in which people's aortas were punctured this way. Two people died, while the other two survived after surgery. All four were women.
Telectronics recalled any unused wires this past fall. In a letter in November to 44,500 doctors, Telectronics noted there is about a 3 percent risk of death or life-threatening complications when taking out a pacemaker lead.
``While the risk of extraction is small, it is clearly greater than the risk of potential failure of this lead,'' the letter said.
Telectronics has set up a toll-free number to give physicians information: (800) 349-9446
Keywords:
FATALITY
Memo: NOTE: below