Medical devicemaker Medtronic has sent out a letter warning doctors that it found a higher rate of failure in its Kappa and Sigma brand pacemakers than it had originally predicted.
The company is predicting that just over 1 percent of Kappa and just under 5 percent of Sigma pacemakers will fail over their remaining estimated lifetime. These failures are caused by separation of wires connecting the electronic circuit to pacemaker components such as the battery or connector, Medtronic said.
The announcement could have broad implications, as about 21,300 implanted pacemakers made between November 2000 and November 2002 could be affected. This includes roughly 6,300 U.S. patients, the company said. Company officials are advising doctors to consider replacing the devices.
To learn more about the announcement:
- read this Modern Healthcare piece (reg. req.)