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Medtronic Sigma Series Pacemakers

2005 Medtronic Sigma Series 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.

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.

Past Safety Warnings Issued for Sigma Series Pacemakers

Medtronic had previously 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. Fortunately this defect was linked to a specific manufacturing flaw and was limited to a small number of devices.

Medtronic offered several suggestions to health care professionals regarding patient care.

  • Replacement is not recommended prior to normal elective replacement.
  • Routine follow up is recommended in accordance with standard practice.
  • Patients should seek attention immediately if they experience a return of symptoms.
  • Device replacement should be determined on a case-by-case basis based upon consultation with patients. The individual patient’s medical history and consideration of the relative risks of an invasive procedure should be examined.

To learn more about legal claims relating to Medtronic Pacemakers, you should consult an attorney who practices in the area of drugs and medical devices.



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