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FDA Calls for Additional Monitoring of Defective Heart Devices

The Food and Drug Administration is calling for additional studies regarding the safety of recalled heart devices made by St. Jude Medical. As we previously reported on this blog, the medical devices have been linked to at least 20 deaths.

The concerns involve leads that connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. As detailed by the FDA, ICDs are used to detect life-threatening heart rhythms and send an electrical shock from the ICD through the lead to the heart.

ICD leads typically have layers of insulation that protect electrical conductor wires inside the lead. However, St. Jude’s Rialta leads were recalled on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires.

This premature insulation failure can impact the lead’s ability to function properly. As highlighted by the FDA, defective devices can cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death.

Although St. Jude issued a recall, approximately 79,000 Riata leads remained implanted in patients in the United States as of 2011. Therefore, the FDA has elected to take a more proactive approach. It now recommends that patients who have implantable heart defibrillators with Riata and Riata ST leads should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead.

The FDA highlights that its recommendation is supported by several studies that have demonstrated that routine imaging of the leads may detect previously unrecognized abnormalities with the insulation. In addition, x-rays or other imaging techniques can help health care providers develop individualized patient treatment plans. The FDA is also cautioning against routine removal of leads without careful evaluation of benefits and risks to the individual patient.