July 19, 2012 — According to an April 18 report submitted to the U.S. Food and Drug Administration (FDA) adverse event reporting system, a doctor found that the St. Jude Durata defibrillator lead had worn through its insulation, exposing the wires and increasing the risk of device malfunction. The St. Jude Durata was intended to replace St. Jude’s Riata defibrillator leads, which were recalled in November 2011 because the wires could pop out of the insulation.
Unfortunately, the Durata and the Riata have a similar design, raising the possibility that the same defect exists in both defibrillator leads. Several studies, including one published this week, have found that 25-30% of the St. Jude Riata defibrillator leads can wear through their silicone insulation (known as externalization). The wires may malfunction, delivering unnecessary shocks or failing to deliver a shock during an emergency. At least 20 deaths were attributed to the defective Riata defibrillator lead. Although not all of the externalized defibrillator leads fail, it is difficult to know whether an exposed lead is functional until a patient suffers an adverse event.
St. Jude intended to fix the Riata defect by making changes to the design. The Durata defibrillator lead has additional layers of insulation, which seems to reduce the rate of failure.
However, based on the doctor’s report to the FDA, it appears that externalization failure may still occur with the Durata design. The doctor first noticed the externalized wires during an X-ray. The patient underwent surgery to remove the defective lead, and the externalization was confirmed.
St. Jude responded to the report by conducting its own internal investigation, which found that the damage to the Durata lead abrasion occurred because it was scraping against another object in the body.
St. Jude has aggressively defended the safety and performance of the Durata defibrillator lead. Dr. Mark Carlson, the Chief Medical Officer of St. Jude Medical, said that “my only comment is that 2.4 years in my view is an early experience, not a mid-term experience. The event-free survival was >99%. Excluding dislodgment and and perforations, namely conductor fractures, in over 8400 implant years. Now this is truly spectacular.”