A recent editorial in Pacing and Clinical Electrophysiology reports findings of perforations in St. Jude Riata defibrillator leads. Coming on the heels of the recent Medtronic defibrillator lead recall, this editorial raises additional manufacturing concerns about some of St. Jude’s newer and thinner leads. These perforations, coupled with their late presentation, pose a duel threat to patients. The lead perforation sometimes is not caught until it is “well beyond the right ventricular free wall” and protruding centimeters into surrounding tissue. This protrusion can lead to complications which can cause a lot of complications, including sudden death.
St. Jude has responded to these concerns by citing product analysis data showing that the perforation rate of St. Jude’s Riata lead wires is lower than the rates reported by similar leads. But, honestly, on the heals of the Medtronic recall, my confidence in reports from medical device companies about their safety and efficacy data is about the same as my confidence in Brittany Spears’ parenting skills.