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St. Jude “Riata” Cardiac Defibrillator Leads Linked to Heart Perforation

Riata defibrillator leads manufactured by St. Jude Medical Inc. have raised concern because they have been linked to heart perforations, according to The Wall St. Journal (St. Jude Defibrillator Wire Gets Scrutiny, November 12, 2007)

Cardiac defibrillators detect irregular heartbeats and shock the heart back into a normal rhythm. Lead wires are fed through a vein to connect the defibrillator to the patient’s heart.

Lead wires from St. Jude’s “Riata” line of defibrillators leads have been linked to instances of heart perforation. Instead of staying attached to the heart, the Riata leads poke holes through the heart and through the patients’ skin. These adverse events may inhibit the lead’s ability to sense abnormal heart rhythms, causing the defibrillator to fail. The heart can bleed into the pericardial sac surrounding it causing cardiac tamponade –a serious condition in which pressure builds around the heart preventing it from beating effectively.

According to St. Jude, 121,000 Riata leads have been implanted so far. The company’s data shows perforation rates of 0.33% in 1,027 patients implanted with Riata leads. Reports published in the journal Heart Rhythm show higher perforation rates. In April 2007, Mass General Hospital reported a 3.8% perforation rate (5 out of 130) with certain Riata lead models. It later reported 3 more perforation cases with 115 other Riata leads. In addition, New York Hospital Queens reported they saw 5 perforations out of 59 Riata leads implanted.

St. Jude Defibrillator Wire Gets Scrutiny, The Wall Street Journal, 11/12/07

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