An estimated 40,000 Medtronic Sigma Series pacemakers have been implanted in patients worldwide. Forty-Three of these have proven to be defective, which was a higher failure rate than expected. Although no deaths have been reported as a result of the defective pacemakers, the flaw poses a serious threat to heart patients that rely on the instrument to maintain correct heart rhythm. It is estimated that around 28,000 Sigma Series pacemakers remain inside patients throughout the world.
2005 Medtronic Pacemaker Recall
In 2005 Medtronic issued a recall on their Sigma Series pacemakers due to a wiring defect that could potentially cause device failure. The wiring defect was traced to a cleaning solvent used during production that causes deterioration of the wires over time. The wiring in question connects the main circuitry of the pacemaker to the device header. Because patients with heart conditions rely on pacemakers to sustain regular heart rhythm, the failure of these devices could be life threatening.
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