Devicemaker Medtronic has sent a letter to doctors warning that the company had found a higher rate of failure in their Kappa and Sigma brand pacemakers than originally predicted.
The failures, according to the letter, are caused by separation of wires that connect the electronic circuit to other pacemaker components such as the battery or connector. Medtronic said it predicts a little more 1% of Kappa and just less than 5% of Sigma pacemakers will fail over the remaining estimated lifetime of the devices. Failure signs include patients becoming dizzy, lightheaded or fainting. Company officials advise doctors to consider replacing the devices in patients who are pacemaker-dependent.