VOL. 124 | NO. 98 | Wednesday, May 20, 2009
Medtronic Warns of Defect with 37,000 Pacemakers
WASHINGTON (AP) - Medtronic Inc. has warned doctors that 37,000 of its pacemakers may have wiring defects that can cause them to malfunction.
The medical device company said in a letter to physicians that the defect affects a subset of its Kappa and Sigma pacemakers, causing them to not respond or run out of battery power. About 1.7 million of the pacemakers have been implanted since 1997, the company estimates.
Minneapolis-based Medtronic said it has received two reports of patient deaths where the pacemakers may have played a role.
The company says physicians should consider removing a pacemaker if their patient depends on the device for daily survival.
"That is the only case where you would recommend perhaps exchanging out the device, and if you look at that population, it was like 10 percent" of the 37,000, Chief Executive Bill Hawkins said on a conference call with analysts.
There are no tests to indicate which devices are more likely to fail, according to the company, and also no programming changes to fix the problems if they occur.
Patients should call their doctor immediately if they experience symptoms, including fainting or lightheadedness, the company said.
Shares of Medtronic fell $2.20, or 6.5 percent, Tuesday to close at $31.76 after the company posted a decline in fourth-quarter earnings.
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