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Medtronic Issues Pacemaker Recall
Posted by: admin in Pharmacy Drugs on October 08th, 2009
LITTLE FALLS, N.J., June 12 — Certain pacemakers manufactured by Medtronic have been withdrawn from the market because of wiring problems, the FDA announced.
Of the more than 1.7 million Kappa and Sigma pacemakers implanted worldwide, about 21,300 are included in the recall.
They include devices in the Kappa Series 600/700/900 and Sigma Series 100/200/300 manufactured primarily between November 2000 and November 2002.
Patients can enter the serial number of their device at this Web site to find out whether it is included in the recall.
The FDA explained that the “devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.”
In its letter to physicians, Medtronic estimated the failure rates of Kappa and Sigma pacemakers to be 1.1% and 4.8%, respectively.
In rare cases, patients who are pacemaker-dependent may experience serious injury or death resulting from the defect, the FDA said.
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