The devices’ maker stands behind Durata leads’ long-term safety and durability, and the devices remain on the market.
A new study of malfunction reports says hundreds of thousands of special wires called “leads” for heart defibrillators made by St. Jude Medical are vulnerable to a problem that can cause unneeded high-voltage shocks or a sudden loss of lifesaving therapy in unsuspecting patients.
The company’s Durata leads are susceptible to internal insulation breaches that “may result in serious adverse events without forewarning,” concludes the paper, which was underwritten by the Minneapolis Heart Institute Foundation. The paper also says standard tests may not uncover these insulation defects.
Losing defibrillator therapy in this way could be fatal because patients may not realize their device won’t correct potentially lethal heart problems like ventricular tachycardia. Conversely, receiving unneeded defibrillator shocks can be psychologically traumatic for some patients.