In 2005, Medtronic issued a recall on its Sigma Series pacemakers because of a wiring defect that could 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.
An estimated 40,000 Medtronic Sigma Series pacemakers have been implanted in patients worldwide. Forty-three of these have proven to be defective. Although no deaths have been reported as a result of the defect, it 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.
Past Safety Warnings Issued for Sigma Series Pacemakers
Medtronic issued a safety warning in 1999 concerning the Sigma Series pacemakers. This warning was issued as a reaction to a pulse generator within the pacemaker that was shown to cause a sudden loss of sensing or pacing output. The defect was linked to a specific manufacturing flaw and was limited to a small number of devices.
To learn more about legal claims relating to Medtronic pacemakers, consult an attorney who practices in the area of drugs and medical devices.